EUROPEANPHARMACOPOEIA10.4 INDEX...EUROPEANPHARMACOPOEIA10.4 Index Index Altizide

EUROPEAN PHARMACOPOEIA 10.4

INDEXTo aid users the index includes a reference to the supplement in which the latest version of a text can be found.For example : Altizide...............................................10.1‑4374means the monograph Altizide can be found on page 4374 of Supplement 10.1.Note that where no reference to a supplement is made, the text can be found in the principal volume.

English index ..................................................................... 5597 Latin index .............................................................................. 5633

General Notices (1) apply to all monographs and other texts 5595

EUROPEAN PHARMACOPOEIA 10.4

5596 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 10.4 Index

1. General notices ......................................................................... 32.1. Apparatus ............................................................................. 152.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes............................................................ 172.2. Physical and physico-chemical methods.......................... 212.2.1. Clarity and degree of opalescence of liquids ................ 212.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ....................... 332.2.16. Melting point - instantaneous method........................ 332.2.17. Drop point ...................................................................... 332.2.18. Freezing point................................................................. 352.2.19. Amperometric titration................................................. 352.2.2. Degree of coloration of liquids..........................10.3-47512.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry..................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................. 372.2.24. Absorption spectrophotometry, infrared.......10.3-47532.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 42

2.2.26. Paper chromatography .................................................. 462.2.27. Thin-layer chromatography.......................................... 472.2.28. Gas chromatography...................................................... 482.2.29. Liquid chromatography....................................10.3-47572.2.3. Potentiometric determination of pH............................. 242.2.30. Size-exclusion chromatography ................................... 512.2.31. Electrophoresis ............................................................... 512.2.32. Loss on drying................................................................ 572.2.33. Nuclear magnetic resonance spectrometry ................ 582.2.34. Thermal analysis ............................................................ 612.2.35. Osmolality....................................................................... 632.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 64

2.2.37. X-ray fluorescence spectrometry ................................. 652.2.38. Conductivity ......................................................10.3-47582.2.39. Molecular mass distribution in dextrans .......10.3-47602.2.4. Approximate pH of solutions ......................................... 252.2.40. Near-infrared spectroscopy .......................................... 702.2.41. Circular dichroism......................................................... 752.2.42. Density of solids............................................................. 762.2.43. Mass spectrometry......................................................... 772.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 79

2.2.45. Supercritical fluid chromatography ............................. 802.2.46. Chromatographic separation techniques .................... 802.2.47. Capillary electrophoresis..................................10.1-43152.2.48. Raman spectroscopy...................................................... 922.2.49. Falling ball and automatic rolling ball viscometermethods ........................................................................10.3-4761

2.2.5. Relative density................................................................. 252.2.54. Isoelectric focusing ........................................................ 952.2.55. Peptide mapping ............................................................ 972.2.56. Amino acid analysis..................................................... 1002.2.57. Inductively coupled plasma-atomic emissionspectrometry ........................................................................... 106

2.2.58. Inductively coupled plasma-mass spectrometry...... 1082.2.59. Glycan analysis of glycoproteins ................................ 1092.2.6. Refractive index................................................................ 262.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 115

2.2.63. Direct amperometric and pulsed electrochemicaldetection .................................................................................. 117

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 118

2.2.65. Voltametric titration .................................................... 119

2.2.66. Detection and measurement of radioactivity ........... 1192.2.7. Optical rotation ................................................................ 262.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.3. Identification...................................................................... 1292.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 129

2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 132

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 133

2.3.4. Odour .............................................................................. 1332.4. Limit tests........................................................................... 1372.4.1. Ammonium .................................................................... 1372.4.10. Lead in sugars............................................................... 1422.4.11. Phosphates .................................................................... 1422.4.12. Potassium...................................................................... 1422.4.13. Sulfates........................................................................... 1422.4.14. Sulfated ash ................................................................... 1422.4.15. Nickel in polyols........................................................... 1432.4.16. Total ash ........................................................................ 1432.4.17. Aluminium ................................................................... 1432.4.18. Free formaldehyde ....................................................... 1432.4.19. Alkaline impurities in fatty oils.................................. 1442.4.2. Arsenic............................................................................. 1372.4.20. Determination of elemental impurities..................... 1442.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 147

2.4.22. Composition of fatty acids by gas chromatography.. 1472.4.23. Sterols in fatty oils........................................................ 1502.4.24. Identification and control of residualsolvents .........................................................................10.1-4323

2.4.25. Ethylene oxide and dioxan.......................................... 1572.4.26. N,N-Dimethylaniline ................................................... 1582.4.27. Heavy metals in herbal drugs and herbal drugpreparations ............................................................................ 158

2.4.28. 2-Ethylhexanoic acid ................................................... 1602.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 161

2.4.3. Calcium ........................................................................... 1382.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 163

2.4.31. Nickel in hydrogenated vegetable oils ....................... 1632.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1632.4.4. Chlorides ......................................................................... 1382.4.5. Fluorides.......................................................................... 1382.4.6. Magnesium ..................................................................... 1382.4.7. Magnesium and alkaline-earth metals ........................ 1392.4.8. Heavy metals................................................................... 1392.4.9. Iron .................................................................................. 1422,4-Dichlorobenzyl alcohol ................................................... 23902.5. Assays ................................................................................. 1672.5.1. Acid value........................................................................ 1672.5.10. Oxygen-flask method .................................................. 1702.5.11. Complexometric titrations.......................................... 1702.5.12. Water : semi-micro determination ............................. 1712.5.13. Aluminium in adsorbed vaccines .............................. 1712.5.14. Calcium in adsorbed vaccines .................................... 1722.5.15. Phenol in immunosera and vaccines......................... 1722.5.16. Protein in polysaccharide vaccines ............................ 1722.5.17. Nucleic acids in polysaccharide vaccines .................. 1722.5.18. Phosphorus in polysaccharide vaccines .................... 1722.5.19. O-Acetyl in polysaccharide vaccines ......................... 1732.5.2. Ester value....................................................................... 1672.5.20. Hexosamines in polysaccharide vaccines.................. 1732.5.21. Methylpentoses in polysaccharide vaccines.............. 1732.5.22. Uronic acids in polysaccharide vaccines ................... 1742.5.23. Sialic acid in polysaccharide vaccines ....................... 1742.5.24. Carbon dioxide in gases .............................................. 1742.5.25. Carbon monoxide in gases ......................................... 1752.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1762.5.27. Oxygen in gases............................................................ 1762.5.28. Water in gases............................................................... 176


Index EUROPEAN PHARMACOPOEIA 10.4

2.5.29. Sulfur dioxide ....................................................10.4-52272.5.3. Hydroxyl value ............................................................... 1672.5.30. Oxidising substances ................................................... 1772.5.31. Ribose in polysaccharide vaccines ............................. 1772.5.32. Water : micro determination....................................... 1782.5.33. Total protein ................................................................. 1782.5.34. Acetic acid in synthetic peptides................................ 1812.5.35. Nitrous oxide in gases ................................................. 1822.5.36. Anisidine value............................................................. 1822.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 182

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 183

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 184

2.5.4. Iodine value .................................................................... 1672.5.40. Methyl, ethyl and isopropyl toluenesulfonate in activesubstances ................................................................................ 185

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in activesubstances ................................................................................ 186

2.5.5. Peroxide value................................................................. 1682.5.6. Saponification value....................................................... 1692.5.7. Unsaponifiable matter ................................................... 1692.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 169

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 170

2.6. Biological tests ................................................................... 1912.6.1. Sterility ............................................................................ 1912.6.10. Histamine...................................................................... 2002.6.11. Depressor substances................................................... 2002.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.......................................10.3-4765

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ............................10.3-4769

2.6.14. Bacterial endotoxins .................................................... 2092.6.15. Prekallikrein activator ................................................. 2132.6.16. Tests for extraneous agents in viral vaccines for humanuse..................................................................................10.2-4579

2.6.17. Test for anticomplementary activity ofimmunoglobulin..................................................................... 216

2.6.18. Test for neurovirulence of live virus vaccines .......... 2182.6.2. Mycobacteria .................................................................. 1942.6.20. Anti-A and anti-B haemagglutinins .......................... 2182.6.21. Nucleic acid amplification techniques....................... 2192.6.22. Activated coagulation factors ..................................... 2242.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 230

2.6.27. Microbiological examination of cell-basedpreparations .................................................................10.3-4773

2.6.30. Monocyte-activation test............................................. 2332.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 239

2.6.32. Test for bacterial endotoxins using recombinantfactor C .........................................................................10.3-4776

2.6.33. Residual pertussis toxin............................................... 2412.6.34. Host-cell protein assays............................................... 2442.6.35. Quantification and characterisation of residualhost-cell DNA ......................................................................... 248

2.6.36. Microbiological examination of live biotherapeuticproducts : tests for enumeration of microbialcontaminants........................................................................... 250

2.6.37. Principles for the detection of extraneous viruses inimmunological veterinary medicinal products using culturemethods ........................................................................10.3-4778

2.6.38. Microbiological examination of live biotherapeuticproducts : tests for specified micro-organisms.................... 255

2.6.7. Mycoplasmas .................................................................. 1942.6.8. Pyrogens.......................................................................... 1992.7. Biological assays ................................................................ 2612.7.1. Immunochemical methods........................................... 2612.7.10. Assay of human coagulation factor VII .................... 280

2.7.11. Assay of human coagulation factor IX ...................... 2812.7.12. Assay of heparin in coagulation factors .................... 2812.7.13. Assay of human anti-D immunoglobulin ................. 2822.7.14. Assay of hepatitis A vaccine.............................10.3-47812.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2852.7.16. Assay of pertussis vaccine (acellular) ........................ 2862.7.17. Assay of human antithrombin III .............................. 2882.7.18. Assay of human coagulation factor II ....................... 2882.7.19. Assay of human coagulation factor X........................ 2892.7.2. Microbiological assay of antibiotics ............................. 2622.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2892.7.21. Assay of human von Willebrand factor..................... 2902.7.22. Assay of human coagulation factor XI ...................... 2912.7.23. Numeration of CD34/CD45+ cells in haematopoieticproducts ................................................................................... 292

2.7.24. Flow cytometry ............................................................ 2932.7.25. Assay of human plasmin inhibitor............................. 2952.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 295

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 296

2.7.29. Nucleated cell count and viability.............................. 2972.7.30. Assay of human protein C .......................................... 2992.7.31. Assay of human protein S ........................................... 3002.7.32. Assay of human α-1-proteinase inhibitor ................. 3002.7.34. Assay of human C1-esterase inhibitor ...................... 3012.7.35. Immunonephelometry for vaccine componentassay ......................................................................................... 301

2.7.4. Assay of human coagulation factor VIII ..................... 2682.7.5. Assay of heparin............................................................. 2692.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2692.7.7. Assay of pertussis vaccine (whole cell)........................ 2742.7.8. Assay of tetanus vaccine (adsorbed)............................ 2752.7.9. Test for Fc function of immunoglobulin..................... 2792.8. Methods in pharmacognosy ............................................ 3052.8.1. Ash insoluble in hydrochloric acid .............................. 3052.8.10. Solubility in alcohol of essential oils.......................... 3062.8.11. Assay of 1,8-cineole in essential oils.......................... 3072.8.12. Essential oils in herbal drugs...................................... 3072.8.13. Pesticide residues ......................................................... 3082.8.14. Tannins in herbal drugs .............................................. 3102.8.15. Bitterness value............................................................. 3102.8.16. Dry residue of extracts ................................................ 3112.8.17. Loss on drying of extracts........................................... 3112.8.18. Determination of aflatoxin B1 in herbal drugs ......... 3112.8.2. Foreign matter ................................................................ 3052.8.20. Herbal drugs : sampling and sample preparation .... 3132.8.21. Test for aristolochic acids in herbal drugs ................ 3142.8.22. Determination of ochratoxin A in herbal drugs ...... 3162.8.23. Microscopic examination of herbal drugs ................ 3172.8.24. Foam index ................................................................... 3172.8.25. High-performance thin-layer chromatography ofherbal drugs and herbal drug preparations ........................ 318

2.8.3. Stomata and stomatal index.......................................... 3052.8.4. Swelling index................................................................. 3062.8.5. Water in essential oils .................................................... 3062.8.6. Foreign esters in essential oils ...................................... 3062.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 306

2.8.8. Odour and taste of essential oils .................................. 3062.8.9. Residue on evaporation of essential oils ..................... 3062.9. Pharmaceutical technical procedures ............................. 3232.9.1. Disintegration of tablets and capsules ......................... 3232.9.10. Ethanol content ............................................................ 3392.9.11. Test for methanol and 2-propanol ............................. 3422.9.12. Sieve test........................................................................ 3432.9.14. Specific surface area by air permeability................... 3432.9.16. Flowability..................................................................... 3462.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 347

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 347



2.9.19. Particulate contamination : sub-visibleparticles.........................................................................10.3-4785

2.9.2. Disintegration of suppositories and pessaries ............ 3252.9.20. Particulate contamination : visible particles ............. 3622.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 363

2.9.23. Gas pycnometric density of solids ............................. 3642.9.25. Dissolution test for medicated chewing gums ......... 3652.9.26. Specific surface area by gas adsorption ..................... 3692.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 372

2.9.29. Intrinsic dissolution..................................................... 3722.9.3. Dissolution test for solid dosage forms ....................... 3262.9.31. Particle size analysis by laser light diffraction.......... 3732.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 377

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)........................ 379

2.9.34. Bulk density and tapped density of powders............ 3842.9.35. Powder fineness............................................................ 3872.9.36. Powder flow .................................................................. 3872.9.37. Optical microscopy...................................................... 3902.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 392

2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 394

2.9.4. Dissolution test for transdermal patches .................... 3332.9.40. Uniformity of dosage units ......................................... 3982.9.41. Friability of granules and spheroids .......................... 4002.9.42. Dissolution test for lipophilic solid dosage forms ... 4012.9.43. Apparent dissolution ................................................... 4032.9.44. Preparations for nebulisation : characterisation....... 4042.9.45. Wettability of porous solids including powders....... 4062.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 409

2.9.49. Powder flow properties by shear cell methods......... 4112.9.5. Uniformity of mass of single-dose preparations ........ 3352.9.52. Scanning electron microscopy ................................... 4142.9.6. Uniformity of content of single-dose preparations.... 3362.9.7. Friability of uncoated tablets ........................................ 3362.9.8. Resistance to crushing of tablets .................................. 3372.9.9. Measurement of consistency by penetrometry .......... 3373.1. Materials used for the manufacture of containers ........ 4233.1.1. Materials for containers for human blood and bloodcomponents (see 3.3.1.) ......................................................... 465

3.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 437

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for solid dosage forms for oraladministration......................................................................... 439

3.1.1.1. Materials based on plasticised poly(vinyl chloride)for containers for human blood and blood components (see3.3.2.)........................................................................................ 465

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (see 3.3.3.) ......................................................... 468

3.1.13. Plastic additives ............................................................ 4413.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 445

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 448

3.1.3. Polyolefins ....................................................................... 4233.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations.. 426

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ................... 427

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ......................... 431

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations .......................... 434

3.1.8. Silicone oil used as a lubricant ..................................... 4363.1.9. Silicone elastomer for closures and tubing ................. 436

3.2. Containers.......................................................................... 4533.2.1. Glass containers for pharmaceutical use..................... 4533.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 459

3.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 460

3.2.3. Sterile plastic containers for human blood and bloodcomponents (see 3.3.4.) ..............................................10.3-4791

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components (see3.3.5.)........................................................................................ 473

3.2.5. Sterile containers of plasticised poly(vinyl chloride)for human blood containing anticoagulant solution (see3.3.6.)........................................................................................ 474

3.2.6. Sets for the transfusion of blood and blood components(see 3.3.7.)................................................................................ 475

3.2.8. Sterile single-use plastic syringes (see 3.3.8.) ..10.3-47923.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 460

3.3. Containers for human blood and blood components, andmaterials used in their manufacture; transfusion sets andmaterials used in their manufacture; syringes .................... 463

3.3.1. Materials for containers for human blood and bloodcomponents ............................................................................. 465

3.3.2. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 465

3.3.3. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 468

3.3.4. Sterile plastic containers for human blood and bloodcomponents ..................................................................10.3-4791

3.3.5. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 473

3.3.6. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 474

3.3.7. Sets for the transfusion of blood and bloodcomponents ............................................................................. 475

3.3.8. Sterile single-use plastic syringes ......................10.3-47923-O-Desacyl-4′-monophosphoryl lipid A............................ 23554. Reagents......................................................................10.4-52314.1. Reagents, standard solutions, buffer solutions ...10.4-52314.1.1. Reagents ...............................................................10.4-52314.1.2. Standard solutions for limit tests ......................10.4-53494.1.3. Buffer solutions ...................................................10.4-53534.2. Volumetric analysis................................................10.4-53604.2.1. Primary standards for volumetric solutions ....10.4-53604.2.2. Volumetric solutions...........................................10.4-53604-Aminobenzoic acid ............................................................. 18195.1. General texts on microbiology ........................................ 6195.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 763

5.11. Characters section in monographs ............................... 7695.1.1. Methods of preparation of sterile products ................ 6195.1.10. Guidelines for using the test for bacterialendotoxins ....................................................................10.3-4802

5.1.11. Determination of bactericidal, fungicidal or yeasticidalactivity of antiseptic medicinal products............................. 643

5.1.12. Depyrogenation of items used in the production ofparenteral preparations...............................................10.3-4806

5.1.2. Biological indicators and related microbial preparationsused in the manufacture of sterile products........................ 622

5.12. Reference standards ........................................................ 7735.1.3. Efficacy of antimicrobial preservation ........................ 6255.14. Gene transfer medicinal products for human use ...... 7795.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceuticaluse..................................................................................10.3-4801

5.1.5. Application of the F concepts to heat sterilisationprocesses .......................................................................10.3-4802

5.15. Functionality-related characteristics of excipients...... 7935.1.6. Alternative methods for control of microbiologicalquality ...................................................................................... 628



5.16. Crystallinity ..................................................................... 7975.17. Recommendations on methods for dosage formstesting....................................................................................... 801

5.1.7. Viral safety ...................................................................... 6375.17.1. Recommendations on dissolution testing................. 8015.17.2. Recommendations on testing of particulatecontamination : visible particles.................................10.3-4809

5.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 638

5.19. Extemporaneous preparation of radiopharmaceuti-cals ............................................................................................ 807

5.1.9. Guidelines for using the test for sterility..................... 6395.2. General texts on biological products .............................. 6475.20. Elemental impurities ...................................................... 8155.21. Chemometric methods applied to analytical data ...... 8195.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 647

5.2.11. Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use............................... 674

5.2.12. Raw materials of biological origin for the productionof cell-based and gene therapy medicinal products ........... 675

5.2.13. Healthy chicken flocks for the production of inactivatedvaccines for veterinary use .........................................10.2-4598

5.2.14. Substitution of in vivo method(s) by in vitromethod(s)for the quality control of vaccines ........................................ 679

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 647

5.22. Names of herbal drugs used in traditional Chinesemedicine .......................................................................10.4-5367

5.2.3. Cell substrates for the production of vaccines for humanuse............................................................................................. 650

5.23. Monographs on herbal drug extracts (informationchapter) .................................................................................... 843

5.2.4. Cell cultures for the production of vaccines forveterinary use...............................................................10.2-4589

5.24. Chemical imaging ........................................................... 8475.2.5. Management of extraneous agents in immunologicalveterinary medicinal products ...................................10.2-4590

5.25. Process analytical technology.............................10.4-53715.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 658

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 661

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 661

5.28. Multivariate statistical process control ..............10.4-53775.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 673

5.3. Statistical analysis of results of biological assays andtests........................................................................................... 685

5.4. Residual solvents ............................................................... 7175.5. Alcoholimetric tables........................................................ 7275.6. Assay of interferons .......................................................... 7415.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ...................... 745

5.8. Pharmacopoeial harmonisation ...................................... 7555.9. Polymorphism ................................................................... 759

AAbacavir sulfate....................................................................... 1733Abbreviations and symbols (1.) .................................................. 3Abelmoschi corolla ................................................................. 1289Absorption spectrophotometry, infrared (2.2.24.) ....10.3-4753Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 42

Acacia ....................................................................................... 1290Acacia, dried dispersion......................................................... 1734Acamprosate calcium ....................................................10.3-4899Acanthopanax bark ................................................................ 1292Acarbose .................................................................................. 1736Acebutolol hydrochloride ...................................................... 1738

Aceclofenac.............................................................................. 1740Acemetacin .............................................................................. 1742Acesulfame potassium............................................................ 1744Acetate trihydrate, sodium ...........................................10.3-5131Acetazolamide......................................................................... 1745Acetic acid, glacial .................................................................. 1746Acetic acid in synthetic peptides (2.5.34.) ............................. 181Acetone .................................................................................... 1747Acetylcholine chloride ........................................................... 1748Acetylcysteine.................................................................10.3-4900β-Acetyldigoxin....................................................................... 1750Acetylene intermix (1 per cent) in nitrogen........................ 1752Acetylsalicylic acid ................................................................. 1753Acetyltryptophan, N- ............................................................. 1755Acetyltyrosine, N- ................................................................... 1757Achyranthes bidentata root ................................................... 1293Aciclovir..........................................................................10.4-5415Acid value (2.5.1.) ..................................................................... 167Acidum picrinicum for homoeopathic preparations ......... 1698Acidum succinicum for homoeopathic preparations ........ 1698Acitretin ................................................................................... 1760Actinobacillosis vaccine (inactivated), porcine .................. 1139Activated charcoal .................................................................. 2162Activated coagulation factors (2.6.22.)................................... 224Adapalene ................................................................................ 1761Additives, plastic (3.1.13.) ....................................................... 441Adenine.................................................................................... 1762Adenosine ................................................................................ 1763Adenovirus vaccine (inactivated), canine............................ 1079Adenovirus vaccine (live), canine................................10.2-4637Adipic acid............................................................................... 1765Adonis vernalis for homoeopathic preparations .......10.1-4369Adrenaline ......................................................................10.3-4901Adrenaline tartrate ................................................................. 1767Adsorption, gas, specific surface area by (2.9.26.)................ 369Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 347

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 311Agar .......................................................................................... 1295Agaricus phalloides for homoeopathic preparations ......... 1699Agnus castus fruit ................................................................... 1295Agnus castus fruit dry extract ............................................... 1296Agrimony................................................................................. 1297Air, medicinal ......................................................................... 1768Air, synthetic medicinal......................................................... 1770Akebia stem ............................................................................. 1298Alanine..................................................................................... 1771Albendazole............................................................................. 1773Albumin solution, human ..................................................... 2832Alchemilla................................................................................ 1300Alcoholimetric tables (5.5.) ..................................................... 727Alcuronium chloride.............................................................. 1774Alendronate trihydrate, sodium ........................................... 3798Alexandrian senna pods ...............................................10.1-4363Alfacalcidol.............................................................................. 1776Alfadex ..................................................................................... 1777Alfentanil hydrochloride hydrate ................................10.3-4903Alfuzosin hydrochloride ........................................................ 1780Alginate, sodium..................................................................... 3799Alginic acid.............................................................................. 1781Alimemazine hemitartrate..................................................... 1782Alkaline impurities in fatty oils (2.4.19.) ............................... 144Alkaline-earth metals and magnesium (2.4.7.)..................... 139Allantoin .................................................................................. 1783Allergen products ..................................................................... 861Allergen products, animal epithelia and outgrowths for... 1854Allergen products, Hymenoptera venoms for..................... 2908Allergen products, mites for.................................................. 3281Allergen products, moulds for .............................................. 3302Allergen products, pollens for............................................... 3583Allium sativum for homoeopathic preparations ................ 1701Allopurinol .............................................................................. 1784all-rac-α-Tocopherol............................................................... 4057



all-rac-α-Tocopheryl acetate.................................................. 4059Almagate .................................................................................. 1786Almond oil, refined ................................................................ 1787Almond oil, virgin .................................................................. 1787Almotriptan malate .......................................................10.1-4373Aloes, Barbados ...................................................................... 1301Aloes, Cape.............................................................................. 1302Aloes dry extract, standardised............................................. 1303Alovudine (18F) injection ....................................................... 1181Alphacyclodextrin .................................................................. 1777Alprazolam .............................................................................. 1788Alprenolol hydrochloride ...................................................... 1790Alprostadil ............................................................................... 1791Alteplase for injection ............................................................ 1793Alternative methods for control of microbiological quality(5.1.6.) ...................................................................................... 628

Altizide............................................................................10.1-4374Alum......................................................................................... 1798Aluminium (2.4.17.)................................................................. 143Aluminium chloride hexahydrate......................................... 1798Aluminium hydroxide, hydrated, for adsorption ............... 1798Aluminium in adsorbed vaccines (2.5.13.)............................ 171Aluminium magnesium silicate ............................................ 1799Aluminium oxide, hydrated .................................................. 1801Aluminium phosphate gel ..................................................... 1802Aluminium phosphate, hydrated.................................10.4-5417Aluminium sodium silicate ................................................... 1803Aluminium stearate................................................................ 1804Aluminium sulfate.................................................................. 1806Alverine citrate........................................................................ 1807Amantadine hydrochloride ................................................... 1808Ambroxol hydrochloride ....................................................... 1809Amfetamine sulfate ................................................................ 1810Amidotrizoate, sodium .......................................................... 3800Amidotrizoic acid dihydrate ................................................. 1812Amikacin ................................................................................. 1813Amikacin sulfate ..................................................................... 1815Amiloride hydrochloride dihydrate ............................10.4-5417Amino acid analysis (2.2.56.) .................................................. 100Aminobenzoic acid, 4- ........................................................... 1819Aminocaproic acid ................................................................. 1821Aminoglutethimide ................................................................ 1821Aminophylline ........................................................................ 4008Aminophylline hydrate .......................................................... 4009Aminosalicylate dihydrate, sodium.............................10.4-5561Amiodarone hydrochloride................................................... 1823Amisulpride............................................................................. 1825Amitriptyline hydrochloride ................................................. 1826Amlodipine besilate................................................................ 1827Ammonia (13N) injection....................................................... 1183Ammonia solution, concentrated ......................................... 1829Ammonio methacrylate copolymer (type A)...................... 1830Ammonio methacrylate copolymer (type B) ...................... 1831Ammonium (2.4.1.).................................................................. 137Ammonium bromide ............................................................. 1832Ammonium carbonicum for homoeopathic prepara-tions........................................................................................ 1701

Ammonium chloride.....................................................10.4-5418Ammonium glycyrrhizate ..................................................... 1833Ammonium hydrogen carbonate ......................................... 1834Amomum fruit........................................................................ 1304Amomum fruit, round ........................................................... 1604Amorolfine hydrochloride..................................................... 1836Amoxicillin sodium................................................................ 1838Amoxicillin trihydrate............................................................ 1840Amperometric detection, direct, and pulsed electrochemicaldetection (2.2.63.) ................................................................... 117

Amperometric titration (2.2.19.) .............................................. 35Amphotericin B .............................................................10.3-4904Ampicillin ................................................................................ 1844Ampicillin sodium.................................................................. 1846Ampicillin trihydrate.............................................................. 1849Amprolium hydrochloride for veterinary use............10.3-4906

Amylmetacresol ...................................................................... 1851Anacardium for homoeopathic preparations...................... 1702Anaemia vaccine (live), chicken, infectious ...............10.2-4655Anaesthetic ether .................................................................... 2577Analysis, thermal (2.2.34.)......................................................... 61Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 392

Anamirta cocculus for homoeopathic preparations .......... 1708Anastrozole.............................................................................. 1852Andrographis herb ................................................................. 1305Anemarrhena asphodeloides rhizome ................................. 1307Angelica archangelica root .................................................... 1309Angelica dahurica root........................................................... 1310Angelica pubescens root ........................................................ 1312Angelica sinensis root ............................................................ 1314Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1858

Animal epithelia and outgrowths for allergen products.... 1854Animal immunosera for human use ...........................10.4-5385Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 884

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 661

Anise oil ................................................................................... 1315Aniseed .................................................................................... 1317Anisidine value (2.5.36.) .......................................................... 182Antazoline hydrochloride...................................................... 1855Anthrax spore vaccine (live) for veterinary use.................. 1055Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 947

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 218Antibiotics, microbiological assay of (2.7.2.) ........................ 262Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 230

Antibodies for human use, monoclonal ................................ 878Anticoagulant and preservative solutions for human blood................................................................................................ 1856

Anticomplementary activity of immunoglobulin (2.6.17.).. 216Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 230

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2835

Anti-D immunoglobulin, human ......................................... 2834Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 282Antimicrobial preservation, efficacy of (5.1.3.) .................... 625Antiseptic medicinal products, determination of bactericidal,fungicidal or yeasticidal activity of (5.1.11.) ....................... 643

Antiserum, European viper venom ...................................... 1174Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1858

Antithrombin III concentrate, human................................. 2835Antithrombin III, human, assay of (2.7.17.) ......................... 288Apis for homoeopathic preparations.................................... 1703Apomorphine hydrochloride hemihydrate ......................... 1862Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 403Application of the F concepts to heat sterilisation processes(5.1.5.) ...........................................................................10.3-4802

Approximate pH of solutions (2.2.4.)....................................... 25Aprepitant................................................................................ 1863Aprotinin ........................................................................10.4-5419Aprotinin concentrated solution .................................10.4-5421Arachis oil, hydrogenated...................................................... 1869Arachis oil, refined ................................................................. 1870Arginine ................................................................................... 1870Arginine aspartate .................................................................. 1871Arginine hydrochloride ......................................................... 1872Argon ....................................................................................... 1873Aripiprazole....................................................................10.4-5424Aristolochic acids in herbal drugs, test for (2.8.21) ............. 314Arnica flower........................................................................... 1318Arnica tincture........................................................................ 1320



Arsenic (2.4.2.) .......................................................................... 137Arsenicum album for homoeopathic preparations ............ 1704Arsenious trioxide for homoeopathic preparations ........... 1704Articaine hydrochloride......................................................... 1876Artichoke leaf .......................................................................... 1321Artichoke leaf dry extract ...................................................... 1323Ascorbate, calcium ................................................................. 2045Ascorbate, sodium.................................................................. 3802Ascorbic acid ........................................................................... 1877Ascorbyl palmitate.........................................................10.3-4907Ash insoluble in hydrochloric acid (2.8.1.) ........................... 305Ash leaf .................................................................................... 1324Ash, sulfated (2.4.14.)............................................................... 142Ash, total (2.4.16.) .................................................................... 143Asparagine monohydrate..............................................10.1-4376Aspartame................................................................................ 1881Aspartic acid............................................................................ 1883Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 307Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 269Assay of heparin (2.7.5.) .......................................................... 269Assay of heparin in coagulation factors (2.7.12.) ................. 281Assay of hepatitis A vaccine (2.7.14.) ..........................10.3-4781Assay of hepatitis B vaccine (rDNA) (2.7.15.)....................... 285Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 300Assay of human anti-D immunoglobulin (2.7.13.) .............. 282Assay of human antithrombin III (2.7.17.)............................ 288Assay of human C1-esterase inhibitor (2.7.34.) .................... 301Assay of human coagulation factor II (2.7.18.)..................... 288Assay of human coagulation factor IX (2.7.11.) ................... 281Assay of human coagulation factor VII (2.7.10.).................. 280Assay of human coagulation factor VIII (2.7.4.) .................. 268Assay of human coagulation factor X (2.7.19.) ..................... 289Assay of human coagulation factor XI (2.7.22.) ................... 291Assay of human plasmin inhibitor (2.7.25.) .......................... 295Assay of human protein C (2.7.30.)........................................ 299Assay of human protein S (2.7.31.) ........................................ 300Assay of human von Willebrand factor (2.7.21.) .................. 290Assay of interferons (5.6.)........................................................ 741Assay of pertussis vaccine (acellular) (2.7.16.)...................... 286Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 274Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 289

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 275Assays (2.5.)............................................................................... 167Astragalus mongholicus root ................................................ 1325Atazanavir sulfate ..........................................................10.1-4378Atenolol...........................................................................10.1-4380Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .................................................................................... 106

Atomoxetine hydrochloride .................................................. 1889Atorvastatin calcium trihydrate ...................................10.4-5425Atovaquone.............................................................................. 1892Atractylodes lancea rhizome ................................................. 1327Atractylodes rhizome, largehead .......................................... 1328Atracurium besilate ................................................................ 1894Atropine ................................................................................... 1897Atropine sulfate....................................................................... 1898Aucklandia root ...................................................................... 1329Aujeszky’s disease vaccine (inactivated) for pigs .......10.2-4619Aujeszky’s disease vaccine (live) for pigs for parenteraladministration..............................................................10.2-4620

Aurothiomalate, sodium........................................................ 3804Aurum chloratum natronatum for homoeopathicpreparations .......................................................................... 1704

Automatic rolling ball and falling ball viscometer methods(2.2.49.) .........................................................................10.3-4761

Avian infectious bronchitis vaccine (inactivated)......10.2-4622Avian infectious bronchitis vaccine (live)...................10.2-4623Avian infectious bursal disease vaccine (inactivated) ....... 10.2-4625

Avian infectious bursal disease vaccine (live) ............10.2-4627

Avian infectious encephalomyelitis vaccine (live) .....10.2-4628Avian infectious laryngotracheitis vaccine (live).......10.2-4630Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .................................................................10.2-4660

Avian paramyxovirus 1 (Newcastle disease) vaccine(live) ..............................................................................10.2-4661

Avian paramyxovirus 3 vaccine (inactivated) forturkeys...........................................................................10.2-4631

Avian tuberculin purified protein derivative....................... 4119Avian viral tenosynovitis vaccine (live) ......................10.2-4632Azaperone for veterinary use ................................................ 1900Azathioprine...................................................................10.3-4907Azelastine hydrochloride ....................................................... 1902Azithromycin .......................................................................... 1904

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 219

Bacampicillin hydrochloride ................................................. 1911Bacitracin................................................................................. 1913Bacitracin zinc................................................................10.3-4913Baclofen ................................................................................... 1921Bacterial endotoxins (2.6.14.).................................................. 209Bacterial endotoxins, guidelines for using the test for(5.1.10.) .........................................................................10.3-4802

Bacterial endotoxins using recombinant factor C, test for(2.6.32.) .........................................................................10.3-4776

Bactericidal, fungicidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) .................. 643

Baical skullcap root .......................................................10.4-5403Bambuterol hydrochloride ...........................................10.3-4917Barbados aloes ........................................................................ 1301Barbary wolfberry fruit.......................................................... 1332Barbital..................................................................................... 1923Barium chloratum for homoeopathic preparations ........... 1705Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1705

Barium sulfate ......................................................................... 1924Basic butylated methacrylate copolymer ............................. 1925BCG for immunotherapy......................................................... 948BCG vaccine, freeze-dried....................................................... 949Bearberry leaf .......................................................................... 1333Beclometasone dipropionate ................................................. 1926Beclometasone dipropionate monohydrate......................... 1929Beeswax, white ........................................................................ 1931Beeswax, yellow....................................................................... 1932Belamcanda chinensis rhizome....................................10.3-4869Belladonna for homoeopathic preparations........................ 1705Belladonna leaf........................................................................ 1336Belladonna leaf dry extract, standardised ........................... 1337Belladonna leaf tincture, standardised................................. 1338Belladonna, prepared ............................................................. 1339Benazepril hydrochloride ...................................................... 1932Bendroflumethiazide.............................................................. 1934Benperidol ............................................................................... 1935Benserazide hydrochloride ...........................................10.4-5431Bentonite.................................................................................. 1938Benzalkonium chloride.................................................10.4-5432Benzalkonium chloride solution..................................10.4-5434Benzathine benzylpenicillin tetrahydrate ............................ 1951Benzathine penicillin G tetrahydrate ................................... 1951Benzathine penicillin V tetrahydrate ................................... 3531Benzathine phenoxymethylpenicillin tetrahydrate ............ 3531Benzbromarone....................................................................... 1942Benzenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.41.)................................................................. 186

Benzethonium chloride ......................................................... 1943Benzocaine......................................................................10.1-4385Benzoic acid ............................................................................ 1945Benzoin, Siam ......................................................................... 1341Benzoin, Sumatra.................................................................... 1341



Benzoin tincture, Siam........................................................... 1342Benzoin tincture, Sumatra..................................................... 1343Benzoyl peroxide, hydrous .................................................... 1946Benzydamine hydrochloride ................................................. 1947Benzyl alcohol ......................................................................... 1949Benzyl benzoate ...................................................................... 1950Benzylpenicillin (benzathine) tetrahydrate ......................... 1951Benzylpenicillin potassium ................................................... 1953Benzylpenicillin (procaine) monohydrate..................10.4-5436Benzylpenicillin sodium ........................................................ 1957Betacarotene ............................................................................ 1959Betacyclodextrin ..................................................................... 1960Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2901Betacyclodextrin, sodium 4-sulfonatobutyl ether .....10.3-5143Betadex..................................................................................... 1960Betahistine dihydrochloride.................................................. 1962Betahistine mesilate................................................................ 1963Betamethasone...............................................................10.3-4918Betamethasone acetate ..................................................10.3-4920Betamethasone dipropionate........................................10.3-4921Betamethasone sodium phosphate....................................... 1970Betamethasone valerate ......................................................... 1971Betaxolol hydrochloride......................................................... 1973Betiatide for radiopharmaceutical preparations ........10.3-4863Bezafibrate ............................................................................... 1975Bicalutamide............................................................................ 1976Bifonazole ................................................................................ 1977Bilberry fruit, dried ................................................................ 1343Bilberry fruit dry extract, fresh, refined and standardised.. 1442Bilberry fruit, fresh................................................................. 1344Biological assays (2.7.) ............................................................. 261Biological assays and tests, statistical analysis of results of(5.3.) ......................................................................................... 685

Biological indicators and related microbial preparations usedin the manufacture of sterile products (5.1.2.) ................... 622

Biological products, general texts on (5.2.) ........................... 647Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 647

Biological tests (2.6.) ................................................................ 191Biotherapeutic products for human use, live ........................ 876Biotherapeutic products (live), microbiological examination of(tests for enumeration of microbial contaminants) (2.6.36.).................................................................................................. 250

Biotherapeutic products (live), microbiological examinationof (tests for specified micro-organisms) (2.6.38.)............... 255

Biotin........................................................................................ 1979Biperiden hydrochloride........................................................ 1980Biphasic isophane insulin injection...................................... 2953Birch leaf .................................................................................. 1345Bisacodyl .................................................................................. 1982Bismuth subcarbonate............................................................ 1983Bismuth subgallate.................................................................. 1984Bismuth subnitrate, heavy ..................................................... 1985Bismuth subsalicylate ............................................................. 1986Bisoprolol fumarate ................................................................ 1986Bistort rhizome ....................................................................... 1347Bitter fennel ............................................................................. 1433Bitter-fennel fruit oil .............................................................. 1348Bitter-fennel herb oil .............................................................. 1350Bitterness value (2.8.15.) .......................................................... 310Bitter-orange epicarp and mesocarp .................................... 1352Bitter-orange flower................................................................ 1353Bitter-orange-epicarp and mesocarp tincture..................... 1353Bitter-orange-flower oil.......................................................... 1550Black cohosh............................................................................ 1355Black horehound..................................................................... 1358Blackcurrant leaf ..................................................................... 1359Bleomycin sulfate...........................................................10.3-4923Blood and blood components, human, empty sterile containersof plasticised poly(vinyl chloride) for (3.3.5.)..................... 473

Blood and blood components, human, materials basedon plasticised poly(vinyl chloride) for containers for(3.3.2.) ...................................................................................... 465

Blood and blood components, human, materials for containersfor (3.3.1.) ................................................................................ 465

Blood and blood components, human, sterile plasticcontainers for (3.3.4.) ..................................................10.3-4791

Blood and blood components, materials based on plasticisedpoly(vinyl chloride) for tubing used in sets for the transfusionof (3.3.3.).................................................................................. 468

Blood and blood components, sets for the transfusion of(3.3.7.) ...................................................................................... 475

Blood containing anticoagulant solution, human, sterilecontainers of plasticised poly(vinyl chloride) for (3.3.6.).. 474

Blood, human anticoagulant and preservative solutionsfor ........................................................................................... 1856

Bogbean leaf ............................................................................ 1360Boiling point (2.2.12.) ................................................................ 31Boldine ..................................................................................... 1990Boldo leaf ................................................................................. 1361Boldo leaf dry extract............................................................. 1363Borage (starflower) oil, refined ............................................. 1992Borax ...............................................................................10.3-4925Bordetella bronchiseptica vaccine (live) for dogs............... 1070Boric acid................................................................................. 1993Botulinum antitoxin ............................................................... 1169Botulinum toxin type A for injection................................... 1993Botulinum toxin type B for injection ................................... 1995Bovine leptospirosis vaccine (inactivated) .......................... 1071Bovine parainfluenza virus vaccine (live)...................10.2-4633Bovine respiratory syncytial virus vaccine (live) .......10.2-4634Bovine rhinotracheitis vaccine (inactivated), infectious ... 1120Bovine rhinotracheitis vaccine (live), infectious .......10.2-4654Bovine serum .......................................................................... 1996Bovine tuberculin purified protein derivative..................... 4120Bovine viral diarrhoea vaccine (inactivated) ...................... 1075Brimonidine tartrate .............................................................. 1998Bromazepam ........................................................................... 1999Bromhexine hydrochloride.................................................... 2000Bromocriptine mesilate.......................................................... 2001Bromperidol ............................................................................ 2003Bromperidol decanoate.......................................................... 2005Brompheniramine maleate .................................................... 2007Bronchitis vaccine (inactivated), infectious, avian ....10.2-4622Bronchitis vaccine (live), infectious, avian .................10.2-4623Brotizolam ............................................................................... 2008Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use........................................................................ 1076

Buccal films ....................................................................10.3-4828Buccal tablets and sublingual tablets...........................10.3-4828Buccal tablets, mucoadhesive.......................................10.3-4828Buckwheat herb ...................................................................... 1364Budesonide .............................................................................. 2009Bufexamac ............................................................................... 2011Buffer solutions (4.1.3.).................................................10.4-5353Buflomedil hydrochloride...................................................... 2012Bulk density and tapped density of powders (2.9.34.) ......... 384Bumetanide ............................................................................. 2014Bupivacaine hydrochloride.................................................... 2015Bupleurum root ...................................................................... 1365Buprenorphine ........................................................................ 2017Buprenorphine hydrochloride .............................................. 2019Bursal disease vaccine (inactivated), infectious,avian ..............................................................................10.2-4625

Bursal disease vaccine (live), infectious, avian...........10.2-4627Buserelin .................................................................................. 2020Buspirone hydrochloride ....................................................... 2022Busulfan ................................................................................... 2024Butcher’s broom...................................................................... 1367Butyl parahydroxybenzoate................................................... 2025Butylated methacrylate copolymer, basic ............................ 1925Butylhydroxyanisole ............................................................... 2026Butylhydroxytoluene .............................................................. 2027



CCabergoline ............................................................................. 2031Cachets....................................................................................... 907Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1707

Cadmium sulfuricum for homoeopathic preparations...... 1707Caffeine .................................................................................... 2032Caffeine monohydrate............................................................ 2033Calcifediol monohydrate ....................................................... 2035Calcipotriol.............................................................................. 2036Calcipotriol monohydrate ..................................................... 2038Calcitonin (salmon)................................................................ 2040Calcitriol .................................................................................. 2043Calcium (2.4.3.)......................................................................... 138Calcium acetate....................................................................... 2044Calcium ascorbate .................................................................. 2045Calcium carbonate.........................................................10.3-4929Calcium carboxymethylcellulose .......................................... 2093Calcium chloride dihydrate..........................................10.3-4929Calcium chloride hexahydrate .............................................. 2047Calcium dobesilate monohydrate ......................................... 2048Calcium edetate, sodium ....................................................... 3807Calcium fluoratum for homoeopathic preparations .......... 1707Calcium folinate hydrate........................................................ 2049Calcium glucoheptonate ........................................................ 2051Calcium gluconate .................................................................. 2052Calcium gluconate, anhydrous.............................................. 2052Calcium gluconate for injection ........................................... 2053Calcium glycerophosphate .................................................... 2054Calcium hydrogen phosphate ............................................... 2055Calcium hydrogen phosphate dihydrate.............................. 2056Calcium hydroxide ................................................................. 2057Calcium in adsorbed vaccines (2.5.14.) ................................. 172Calcium iodatum for homoeopathic preparations ............. 1708Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1708

Calcium lactate........................................................................ 2058Calcium lactate monohydrate ......................................10.4-5441Calcium lactate pentahydrate.......................................10.4-5441Calcium lactate trihydrate ............................................10.4-5442Calcium levofolinate hydrate ................................................ 2060Calcium levulinate dihydrate ................................................ 2062Calcium pantothenate ...................................................10.4-5442Calcium pentetate (sodium) for radiopharmaceuticalpreparations .......................................................................... 1223

Calcium phosphate ................................................................. 2065Calcium stearate ..................................................................... 2065Calcium sulfate dihydrate.............................................10.3-4930Calendula flower............................................................10.1-4353Calf coronavirus diarrhoea vaccine (inactivated)......10.2-4635Calf rotavirus diarrhoea vaccine (inactivated)...........10.2-4636Calicivirosis vaccine (inactivated), feline ............................ 1106Calicivirosis vaccine (live), feline ................................10.2-4650Camphor, D-............................................................................ 2067Camphor, racemic .................................................................. 2069Candesartan cilexetil .............................................................. 2070Canine adenovirus vaccine (inactivated)............................. 1079Canine adenovirus vaccine (live).................................10.2-4637Canine distemper vaccine (live) ..................................10.2-4639Canine leptospirosis vaccine (inactivated) .......................... 1082Canine parainfluenza virus vaccine (live) ..................10.2-4640Canine parvovirosis vaccine (inactivated)........................... 1085Canine parvovirosis vaccine (live)...............................10.2-4641Cape aloes................................................................................ 1302Cape jasmine fruit .................................................................. 1369Capecitabine............................................................................ 2072Capillary electrophoresis (2.2.47.) ...............................10.1-4315Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3808Caprylic acid ........................................................................... 2073Caprylocaproyl macrogolglycerides ..................................... 2074Capsicum ................................................................................. 1371

Capsicum oleoresin, refined and standardised ................... 1373Capsicum soft extract, standardised .................................... 1374Capsicum tincture, standardised .......................................... 1375Capsules ..................................................................................... 906Capsules and tablets, disintegration of (2.9.1.) ..................... 323Capsules, gastro-resistant ........................................................ 907Capsules, hard ........................................................................... 906Capsules, intrauterine .............................................................. 914Capsules, modified-release ...................................................... 907Capsules, oromucosal....................................................10.3-4828Capsules, rectal ......................................................................... 934Capsules, soft............................................................................. 906Capsules, vaginal....................................................................... 941Captopril .................................................................................. 2075Caraway fruit..................................................................10.3-4870Caraway oil .............................................................................. 1377Carbachol................................................................................. 2078Carbamazepine ..............................................................10.4-5444Carbasalate calcium................................................................ 2080Carbidopa ................................................................................ 2081Carbimazole ............................................................................ 2083Carbocisteine........................................................................... 2084Carbomers ......................................................................10.4-5445Carbon dioxide ....................................................................... 2086Carbon dioxide in gases (2.5.24.) ........................................... 174Carbon monoxide................................................................... 2088Carbon monoxide (15O) ......................................................... 1184Carbon monoxide in gases (2.5.25.)....................................... 175Carbon monoxide intermix (5 per cent) in nitrogen ......... 2089Carboplatin.............................................................................. 2089Carboprost trometamol ......................................................... 2090Carboxymethylcellulose......................................................... 2092Carboxymethylcellulose calcium.......................................... 2093Carboxymethylcellulose sodium........................................... 2093Carboxymethylcellulose sodium, cross-linked ................... 2318Carboxymethylcellulose sodium, low-substituted.............. 2094Carmellose............................................................................... 2092Carmellose calcium ................................................................ 2093Carmellose sodium................................................................. 2093Carmellose sodium and microcrystalline cellulose............ 3269Carmellose sodium, low-substituted.................................... 2094Carmustine .............................................................................. 2095Carnauba wax.......................................................................... 2096Carprofen for veterinary use ................................................. 2097Carrageenan ............................................................................ 2098Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use (5.2.11.) ............... 674

Carteolol hydrochloride......................................................... 2099Carvedilol ................................................................................ 2101Cascara..................................................................................... 1378Cascara dry extract, standardised......................................... 1380Cassia oil .................................................................................. 1381Castor oil, hydrogenated...............................................10.1-4389Castor oil, polyoxyl................................................................. 3144Castor oil, polyoxyl hydrogenated........................................ 3144Castor oil, refined ................................................................... 2103Castor oil, virgin ..................................................................... 2104Catgut, sterile .......................................................................... 1269Catgut, sterile, in distributor for veterinary use ................. 1281CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 292

Cefaclor.................................................................................... 2105Cefadroxil monohydrate........................................................ 2106Cefalexin monohydrate.......................................................... 2108Cefalotin sodium .................................................................... 2109Cefamandole nafate................................................................ 2111Cefapirin sodium.................................................................... 2112Cefatrizine propylene glycol.................................................. 2113Cefazolin sodium.................................................................... 2114Cefepime dihydrochloride monohydrate ............................ 2117Cefixime................................................................................... 2119Cefoperazone sodium ............................................................ 2120Cefotaxime sodium ................................................................ 2122



Cefoxitin sodium .................................................................... 2124Cefpodoxime proxetil ............................................................ 2126Cefprozil monohydrate .......................................................... 2128Cefradine ................................................................................. 2130Ceftazidime pentahydrate...................................................... 2132Ceftazidime pentahydrate with sodium carbonate forinjection ................................................................................. 2134

Ceftriaxone sodium................................................................ 2136Cefuroxime axetil ................................................................... 2138Cefuroxime sodium................................................................ 2139Celandine, greater................................................................... 1463Celecoxib ................................................................................. 2141Celiprolol hydrochloride ..............................................10.3-4930Cell count and viability, nucleated (2.7.29.).......................... 297Cell cultures for the production of vaccines for veterinary use(5.2.4.) ...........................................................................10.2-4589

Cell substrates for the production of vaccines for human use(5.2.3.) ...................................................................................... 650

Cell-based and gene therapy medicinal products, raw materialsof biological origin for the production of (5.2.12.) ............ 675

Cell-based preparations, microbiological examination of(2.6.27.) .........................................................................10.3-4773

Cellulose acetate ..................................................................... 2143Cellulose acetate butyrate ...................................................... 2144Cellulose acetate phthalate .................................................... 2145Cellulose, microcrystalline ...........................................10.4-5446Cellulose (microcrystalline) and carmellose sodium......... 3269Cellulose, powdered ......................................................10.4-5450Centaury .................................................................................. 1382Centella .................................................................................... 1383Cetirizine dihydrochloride .................................................... 2153Cetostearyl alcohol ........................................................10.3-4932Cetostearyl alcohol (type A), emulsifying ........................... 2156Cetostearyl alcohol (type B), emulsifying............................ 2157Cetostearyl isononanoate ...................................................... 2159Cetostearyl sulfate, sodium ................................................... 3810Cetrimide................................................................................. 2159Cetyl alcohol............................................................................ 2160Cetyl palmitate ........................................................................ 2160Cetylpyridinium chloride ...................................................... 2161Ceylon cinnamon bark oil ..................................................... 1391Ceylon cinnamon leaf oil....................................................... 1391CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 296

Chamomile flower, Roman ................................................... 1384Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ................... 379

Characterisation of crystalline solids by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 115

Characterisation of preparations for nebulisation (2.9.44.).. 404Characters section in monographs (5.11.) ............................ 769Charcoal, activated ................................................................. 2162Chemical imaging (5.24.) ........................................................ 847Chemical precursors for radiopharmaceuticalpreparations ............................................................................ 863

Chemometric methods applied to analytical data (5.21.) ... 819Chenodeoxycholic acid ......................................................... 2163Chewable tablets ....................................................................... 939Chewing gums, medicated ...................................................... 907Chewing gums, medicated, dissolution test for (2.9.25.)..... 365Chicken anaemia vaccine (live), infectious ................10.2-4655Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.) ........... 647

Chinese goldthread rhizome ........................................10.3-4871Chitosan hydrochloride ......................................................... 2164Chlamydiosis vaccine (inactivated), feline ......................... 1108Chloral hydrate ....................................................................... 2165Chlorambucil .......................................................................... 2166Chloramine.............................................................................. 4074Chloramphenicol .................................................................... 2167Chloramphenicol palmitate................................................... 2168Chloramphenicol sodium succinate..................................... 2170Chlorcyclizine hydrochloride................................................ 2171

Chlordiazepoxide.................................................................... 2172Chlordiazepoxide hydrochloride .......................................... 2173Chlorhexidine diacetate ......................................................... 2174Chlorhexidine digluconate solution ..................................... 2176Chlorhexidine dihydrochloride ............................................ 2178Chlorides (2.4.4.) ...................................................................... 138Chlormadinone acetate.......................................................... 2180Chlorobutanol ......................................................................... 2182Chlorobutanol hemihydrate .................................................. 2183Chlorocresol ............................................................................ 2184Chloroquine phosphate ......................................................... 2185Chloroquine sulfate ................................................................ 2186Chlorphenamine maleate ...................................................... 2187Chlorpromazine hydrochloride ...................................10.4-5454Chlorprothixene hydrochloride ............................................ 2189Chlortalidone .......................................................................... 2191Chlortetracycline hydrochloride..................................10.1-4390Cholecalciferol ........................................................................ 2195Cholecalciferol concentrate (oily form)............................... 2197Cholecalciferol concentrate (powder form) ........................ 2198Cholecalciferol concentrate (water-dispersible form)........ 2199Cholera vaccine (inactivated), fowl ...................................... 1117Cholera vaccine (inactivated, oral)......................................... 951Cholesterol............................................................................... 2201Cholesterol for parenteral use ............................................... 2202Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 163Choline ([11C]methyl) injection............................................ 1185Chondroitin sulfate sodium .................................................. 2203Chromatographic separation techniques (2.2.46.) ................. 80Chromatography, gas (2.2.28.).................................................. 48Chromatography, liquid (2.2.29.) ................................10.3-4757Chromatography, paper (2.2.26.) ............................................. 46Chromatography, size-exclusion (2.2.30.) ............................... 51Chromatography, supercritical fluid (2.2.45.)......................... 80Chromatography, thin-layer (2.2.27.) ...................................... 47Chromium (51Cr) edetate injection ...................................... 1186Chymotrypsin ......................................................................... 2205Ciclesonide .............................................................................. 2206Ciclopirox .......................................................................10.4-5456Ciclopirox olamine ........................................................10.4-5457Ciclosporin .............................................................................. 2210Cilastatin sodium.................................................................... 2212Cilazapril.................................................................................. 2214Cimetidine ............................................................................... 2215Cimetidine hydrochloride ..................................................... 2217Cinchocaine hydrochloride ................................................... 2218Cinchona bark......................................................................... 1387Cinchona liquid extract, standardised ................................. 1389Cineole ..................................................................................... 2220Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 307Cineole type niaouli oil.......................................................... 1554Cinnamon................................................................................ 1390Cinnamon bark oil, Ceylon................................................... 1391Cinnamon leaf oil, Ceylon..................................................... 1391Cinnarizine.............................................................................. 2221Ciprofibrate ............................................................................. 2222Ciprofloxacin........................................................................... 2223Ciprofloxacin hydrochloride ................................................. 2225Circular dichroism (2.2.41.) ...................................................... 75Cisatracurium besilate ........................................................... 2226Cisplatin................................................................................... 2231Citalopram hydrobromide..................................................... 2232Citalopram hydrochloride ..................................................... 2234Citric acid ................................................................................ 2235Citric acid monohydrate ........................................................ 2236Citronella oil............................................................................ 1392Cladribine ................................................................................ 2237Clarithromycin........................................................................ 2238Clarity and degree of opalescence of liquids (2.2.1.).............. 21Clary sage oil ........................................................................... 1393Classical swine-fever vaccine (live, prepared in cellcultures) ........................................................................10.2-4667

Clazuril for veterinary use..................................................... 2241



Clebopride malate .................................................................. 2243Clemastine fumarate .............................................................. 2244Clematis armandii stem......................................................... 1394Clenbuterol hydrochloride .................................................... 2246Clindamycin hydrochloride .................................................. 2247Clindamycin phosphate ......................................................... 2248Clioquinol................................................................................ 2251Clobazam................................................................................. 2252Clobetasol propionate ...................................................10.1-4392Clobetasone butyrate.............................................................. 2255Clodronate disodium tetrahydrate ....................................... 2257Clofazimine ............................................................................. 2258Clofibrate ................................................................................. 2259Clomifene citrate ...........................................................10.2-4673Clomipramine hydrochloride ............................................... 2261Clonazepam............................................................................. 2263Clonidine hydrochloride........................................................ 2264Clopamide ............................................................................... 2265Clopidogrel besilate ................................................................ 2267Clopidogrel hydrochloride .................................................... 2268Clopidogrel hydrogen sulfate ................................................ 2270Clorazepate, dipotassium monohydrate .............................. 2439Closantel sodium dihydrate for veterinary use................... 2272Clostridium botulinum vaccine for veterinary use ............ 1087Clostridium chauvoei vaccine for veterinary use ............... 1088Clostridium novyi (type B) vaccine for veterinary use...... 1088Clostridium perfringens vaccine for veterinary use........... 1090Clostridium septicum vaccine for veterinary use............... 1092Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.) ......... 431

Closures and containers for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 459

Closures and tubing, silicone elastomer for (3.1.9.) ............. 436Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ...................................................................................... 460

Clotrimazole............................................................................ 2273Clove................................................................................10.3-4873Clove oil ................................................................................... 1396Cloxacillin sodium ................................................................. 2275Clozapine ................................................................................. 2276Coagulation factor II, human, assay of (2.7.18.)................... 288Coagulation factor IX, human .............................................. 2846Coagulation factor IX, human, assay of (2.7.11.) ................. 281Coagulation factor IX (rDNA) concentrated solution,human ...........................................................................10.3-5007

Coagulation factor IX (rDNA) powder for solution forinjection, human..........................................................10.3-5012

Coagulation factor VII, human............................................. 2838Coagulation factor VII, human, assay of (2.7.10.)................ 280Coagulation factor VIIa (rDNA) concentrated solution,human .................................................................................... 2840

Coagulation factor VIII, human ........................................... 2844Coagulation factor VIII, human, assay of (2.7.4.) ................ 268Coagulation factor VIII (rDNA), human ............................ 2845Coagulation factor X, assay of (2.7.19.) ................................. 289Coagulation factor XI, human .............................................. 2855Coagulation factor XI, human, assay of (2.7.22.) ................. 291Coagulation factors, activated (2.6.22.) ................................. 224Coagulation factors, assay of heparin (2.7.12.) ..................... 281Coated granules ........................................................................ 912Coated tablets............................................................................ 938Cocaine hydrochloride........................................................... 2278Coccidiosis vaccine (live) for chickens .......................10.2-4642Cocculus for homoeopathic preparations ........................... 1708Cocoa butter............................................................................ 2279Coconut oil, refined................................................................ 2279Cocoyl caprylocaprate............................................................ 2280Codeine hydrochloride dihydrate......................................... 2281Codeine monohydrate...................................................10.3-4933Codeine phosphate hemihydrate .................................10.3-4935Codeine phosphate sesquihydrate ........................................ 2288Codergocrine mesilate ........................................................... 2290

Cod-liver oil, farmed.....................................................10.3-4937Cod-liver oil (type A)............................................................. 2295Cod-liver oil (type B) ............................................................. 2299Codonopsis root ..................................................................... 1397Coix seed.................................................................................. 1398Cola .......................................................................................... 1400Colchicine................................................................................ 2303Cold-water vibriosis vaccine (inactivated) for salmonids.. 1163Colestyramine ......................................................................... 2305Colibacillosis vaccine (inactivated), neonatal piglet .......... 1132Colibacillosis vaccine (inactivated), neonatal ruminant.... 1133Colistimethate sodium..................................................10.3-4941Colistin sulfate ...............................................................10.3-4944Colloidal anhydrous silica ..................................................... 3787Colloidal hydrated silica ........................................................ 3788Colloidal silica, hydrophobic ................................................ 3789Colloidal silver ...............................................................10.3-5129Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 296

Colophony ............................................................................... 1401Coloration of liquids (2.2.2.) ........................................10.3-4751Common selfheal fruit-spike ................................................ 1401Common stinging nettle for homoeopathic preparations.. 1728Comparative table of porosity of sintered-glass filters(2.1.2.) ........................................................................................ 15

Complexometric titrations (2.5.11.) ....................................... 170Composition of fatty acids by gas chromatography(2.4.22.) .................................................................................... 147

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) .................................................................................... 161

Compressed lozenges ....................................................10.3-4827Concentrated solutions for haemodialysis .......................... 2798Concentrated solutions for haemofiltration andhaemodiafiltration ................................................................ 2801

Concentrates for injections or infusions................................ 924Concentrates for intrauterine solutions ................................. 914Conductivity (2.2.38.) ...................................................10.3-4758Coneflower herb, purple ........................................................ 1589Coneflower root, narrow-leaved ........................................... 1548Coneflower root, pale............................................................. 1568Coneflower root, purple......................................................... 1591Conjugated estrogens ............................................................. 2561Conjugated polysaccharide vaccines for human use, carrierproteins for the production of (5.2.11.) ............................... 674

Consistency by penetrometry, measurement of (2.9.9.) ...... 337Containers (3.2.) ....................................................................... 453Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.) ......... 431

Containers and closures for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 459

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ................................................................................... 460

Containers for aqueous solutions for intravenous infusion,materials based on, plasticised poly(vinyl chloride) for(3.1.14.) .................................................................................... 445

Containers for human blood and blood components, andmaterials used in their manufacture; transfusion sets andmaterials used in their manufacture; syringes (3.3.).......... 463

Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.3.2.)......... 465

Containers for human blood and blood components, materialsfor (3.3.1.) ................................................................................ 465

Containers for human blood and blood components, plastic,sterile (3.3.4.)................................................................10.3-4791

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) .................................................................................... 437

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.)........ 427

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for (3.1.4.) .. 426



Containers for pharmaceutical use, glass (3.2.1.) ................. 453Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) ................................ 448

Containers for solid dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.) .................................................................................... 439

Containers, materials used for the manufacture of (3.1.).... 423Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.3.5.)..................... 473

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.3.6.) .............. 474

Contamination, microbial : microbial enumeration tests(2.6.12.) .........................................................................10.3-4765

Contamination, microbial : microbial enumeration tests (livebiotherapeutic products) (2.6.36.) ........................................ 250

Contamination, microbial : test for specified micro-organisms(2.6.13.) .........................................................................10.3-4769

Contamination, microbial : tests for specified micro-organisms(live biotherapeutic products) (2.6.38.) ............................... 255

Contamination, particulate, recommendations on testing of :visible particles (5.17.2.) ............................................10.3-4809

Contamination, particulate : sub-visible particles(2.9.19.) .........................................................................10.3-4785

Content uniformity of single-dose preparations (2.9.6.) ..... 336Control of impurities in substances for pharmaceutical use(5.10.) ....................................................................................... 763

Control of microbiological quality, alternative methods for(5.1.6.) ...................................................................................... 628

Copolymer, basic butylated methacrylate ........................... 1925Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 3140Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 3214Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ............................................................................. 3216

Copolymer, methacrylic acid – methyl methacrylate(1:1) ........................................................................................ 3217

Copolymer, methacrylic acid - methyl methacrylate(1:2) ........................................................................................ 3218

Copolymer (type A), ammonio methacrylate..................... 1830Copolymer (type B), ammonio methacrylate ..................... 1831Copovidone ....................................................................10.3-4946Copper acetate monohydrate for homoeopathicpreparations .......................................................................... 1711

Copper for homoeopathic preparations .............................. 1712Copper sulfate ......................................................................... 2313Copper sulfate pentahydrate ................................................. 2314Copper tetramibi tetrafluoroborate for radiopharmaceuticalpreparations .......................................................................... 1187

Coriander................................................................................. 1403Coriander oil ........................................................................... 1404Coronavirus diarrhoea vaccine (inactivated), calf ....10.2-4635Cortisone acetate .................................................................... 2315Corydalis rhizome .................................................................. 1405Cotton, absorbent ................................................................... 2316Cottonseed oil, hydrogenated .............................................. 2317Couch grass rhizome.............................................................. 1407Creams ....................................................................................... 936Cresol, crude ........................................................................... 2318Crocus for homoeopathic preparations ............................... 1710Cromoglicate, sodium...................................................10.4-5563Croscarmellose sodium ......................................................... 2318Crospovidone .......................................................................... 2319Crotamiton .............................................................................. 2321Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.)............... 379

Crystalline solids, characterisation by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 115

Crystallinity (5.16.)................................................................... 797Cuprum aceticum for homoeopathic preparations............ 1711Cuprum metallicum for homoeopathic preparations........ 1712Cutaneous application, liquid preparations for .................... 916Cutaneous application, powders for....................................... 925Cutaneous application, semi-solid preparations for ............ 935Cutaneous application, veterinary liquid preparations for.. 941

Cutaneous foams ...................................................................... 916Cutaneous patches .................................................................... 935Cyanocobalamin ............................................................10.3-4949Cyanocobalamin (57Co) capsules .......................................... 1188Cyanocobalamin (57Co) solution .......................................... 1188Cyanocobalamin (58Co) capsules .......................................... 1189Cyanocobalamin (58Co) solution .......................................... 1189Cyathula root..................................................................10.3-4874Cyclamate, sodium ................................................................. 3814Cyclizine hydrochloride................................................10.3-4951Cyclopentolate hydrochloride ............................................... 2324Cyclophosphamide ................................................................. 2326Cyproheptadine hydrochloride 1.5-hydrate ...............10.4-5458Cyproterone acetate................................................................ 2327Cysteine hydrochloride monohydrate.................................. 2329Cystine ..................................................................................... 2331Cytarabine ............................................................................... 2332

DDacarbazine............................................................................. 2337Dalteparin sodium.................................................................. 2338Danaparoid sodium.......................................................10.3-4955Dandelion herb with root ...................................................... 1408Dandelion root........................................................................ 1409Dapsone ................................................................................... 2342Daunorubicin hydrochloride ................................................ 2343D-Camphor.............................................................................. 2067Decyl oleate ............................................................................. 2344Deferasirox .....................................................................10.3-4957Deferiprone ............................................................................. 2344Deferiprone oral solution .............................................10.3-4959Deferiprone tablets ........................................................10.3-4960Deferoxamine mesilate........................................................... 2347Degree of coloration of liquids (2.2.2.) .......................10.3-4751Dembrexine hydrochloride monohydrate for veterinaryuse........................................................................................... 2350

Demeclocycline hydrochloride ....................................10.1-4397Demonstration of uniformity of dosage units using largesample sizes (2.9.47.).............................................................. 409

Density of powders, bulk density and tapped (2.9.34.)........ 384Density of solids (2.2.42.) .......................................................... 76Density of solids, gas pycnometric (2.9.23.).......................... 364Density, relative (2.2.5.) ............................................................. 25Dental preparations.......................................................10.3-4825Dental type silica .................................................................... 3788Depressor substances (2.6.11.) ................................................ 200Deptropine citrate................................................................... 2353Depyrogenation of items used in the production of parenteralpreparations (5.1.12.) ..................................................10.3-4806

Dequalinium chloride ............................................................ 2354Desacyl-4′-monophosphoryl lipid A, 3-O-.......................... 2355Desflurane................................................................................ 2357Desipramine hydrochloride................................................... 2358Deslanoside ............................................................................. 2359Desloratadine .......................................................................... 2360Desmopressin .......................................................................... 2361Desogestrel .............................................................................. 2363Detection and measurement of radioactivity (2.2.66.) ........ 119Detection, direct amperometric and pulsed electrochemical(2.2.63.) .................................................................................... 117

Detector tubes, gas (2.1.6.) ........................................................ 17Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 311Determination of bactericidal, fungicidal or yeasticidal activityof antiseptic medicinal products (5.1.11.) ........................... 643

Determination of elemental impurities (2.4.20.) .................. 144Determination of nitrogen by sulfuric acid digestion(2.5.9.) ...................................................................................... 170

Determination of primary aromatic amino-nitrogen(2.5.8.) ...................................................................................... 169

Determination of water by distillation (2.2.13.) ..................... 31Detomidine hydrochloride for veterinary use .................... 2364Devil’s claw dry extract .......................................................... 1410



Devil’s claw root ...................................................................... 1411Dexamethasone..............................................................10.3-4961Dexamethasone acetate.................................................10.3-4963Dexamethasone isonicotinate ......................................10.4-5463Dexamethasone sodium phosphate...................................... 2370Dexamfetamine sulfate .......................................................... 2373Dexchlorpheniramine maleate.............................................. 2374Dexpanthenol.................................................................10.4-5464Dextran 1 for injection........................................................... 2376Dextran 40 for injection......................................................... 2377Dextran 60 for injection......................................................... 2378Dextran 70 for injection......................................................... 2379Dextranomer ........................................................................... 2380Dextrans, molecular mass distribution in (2.2.39.) ...10.3-4760Dextrin ..................................................................................... 2380Dextromethorphan hydrobromide....................................... 2381Dextromoramide tartrate ...................................................... 2382Dextropropoxyphene hydrochloride.................................... 2383Dextrose................................................................................... 2758Dextrose monohydrate........................................................... 2761Diacerein.................................................................................. 2384Diazepam................................................................................. 2386Diazoxide ................................................................................. 2388Dibrompropamidine diisetionate ......................................... 2388Dibutyl phthalate .................................................................... 2389Dichlorobenzyl alcohol, 2,4- ................................................. 2390Dichloromethane .................................................................... 3235Diclazuril for veterinary use.................................................. 2391Diclofenac potassium ............................................................. 2393Diclofenac sodium.................................................................. 2394Dicloxacillin sodium .............................................................. 2396Dicyclomine hydrochloride................................................... 2397Dicycloverine hydrochloride................................................. 2397Didanosine .............................................................................. 2398Dienogest ................................................................................. 2400Diethyl phthalate .................................................................... 2402Diethylcarbamazine citrate.................................................... 2403Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)................................................................. 163

Diethylene glycol monoethyl ether ...................................... 2404Diethylene glycol palmitostearate......................................... 2405Diethylstilbestrol..................................................................... 2406Diffraction, laser light, particle size analysis by (2.9.31.) ... 373Difloxacin hydrochloride trihydrate for veterinary use..... 2407Digitalis for homoeopathic preparations............................. 1712Digitalis leaf............................................................................. 1412Digitoxin .................................................................................. 2409Digoxin .................................................................................... 2410Dihydralazine sulfate, hydrated ...................................10.4-5465Dihydrocodeine hydrogen tartrate ....................................... 2414Dihydroergocristine mesilate ................................................ 2415Dihydroergotamine mesilate................................................. 2418Dihydrostreptomycin sulfate for veterinary use ................. 2420Dihydrotachysterol ................................................................. 2422Diltiazem hydrochloride........................................................ 2423Dimenhydrinate...................................................................... 2425Dimercaprol ............................................................................ 2426Dimethyl sulfoxide ........................................................10.3-4965Dimethylacetamide ................................................................ 2428Dimethylaniline, N,N- (2.4.26.) .............................................. 158Dimeticone .............................................................................. 2429Dimetindene maleate ............................................................. 2429Dinoprost trometamol ........................................................... 2431Dinoprostone .......................................................................... 2432Dioscorea nipponica rhizome ............................................... 1413Dioscorea oppositifolia rhizome........................................... 1414Diosmin ................................................................................... 2433Dioxan and ethylene oxide (2.4.25.)....................................... 157Dip concentrates ....................................................................... 942Diphenhydramine hydrochloride ......................................... 2435Diphenoxylate hydrochloride................................................ 2436Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 295

Diphtheria and tetanus vaccine (adsorbed) ...............10.3-4831Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).........................................................................10.3-4831

Diphtheria antitoxin............................................................... 1170Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed) ....................................................................10.3-4832

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed) ......................................................10.3-4834

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)......10.3-4835

Diphtheria, tetanus and pertussis (whole cell) vaccine(adsorbed) ....................................................................10.3-4836

Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)....................10.3-4838

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4839

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ....................10.3-4841

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)........10.3-4843

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ......................................................10.3-4844

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4846

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ......................................................10.3-4849

Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) ...............................10.3-4851

Diphtheria, tetanus, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ....................................................................10.3-4853

Diphtheria vaccine (adsorbed)................................................ 977Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 269Diphtheria vaccine (adsorbed, reduced antigen content) ... 978Dipivefrine hydrochloride ..................................................... 2437Dipotassium clorazepate monohydrate ............................... 2439Dipotassium phosphate ................................................10.3-4966Diprophylline .................................................................10.1-4399Dipyridamole .......................................................................... 2442Direct amperometric and pulsed electrochemical detection(2.2.63.) .................................................................................... 117

Dirithromycin ......................................................................... 2444Disintegration of suppositories and pessaries (2.9.2.) ......... 325Disintegration of tablets and capsules (2.9.1.) ...................... 323Disodium clodronate tetrahydrate ....................................... 2257Disodium edetate.................................................................... 2445Disodium etidronate .............................................................. 2589Disodium pamidronate pentahydrate .................................. 3474Disodium phosphate .....................................................10.3-4966Disodium phosphate dihydrate....................................10.3-4967Disodium phosphate dodecahydrate...........................10.3-4967Disopyramide.................................................................10.4-5466Disopyramide phosphate ....................................................... 2449Dispersible tablets..................................................................... 939Dissolution, apparent (2.9.43.)................................................ 403Dissolution, intrinsic (2.9.29.) ................................................ 372Dissolution test for lipophilic solid dosage forms (2.9.42.).. 401Dissolution test for medicated chewing gums (2.9.25.)....... 365Dissolution test for solid dosage forms (2.9.3.) .................... 326Dissolution test for transdermal patches (2.9.4.).................. 333Dissolution testing, recommendations on (5.17.1.) ............. 801Distemper vaccine (live), canine..................................10.2-4639Distemper vaccine (live) for mustelids .......................10.2-4645Distillation range (2.2.11.) ......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .................................................................................... 392

Disulfiram................................................................................ 2450Dithranol ................................................................................. 2451DL-Lysine acetylsalicylate..............................................10.3-5055DL-Methionine ........................................................................ 3225



DL-α-Tocopheryl hydrogen succinate................................... 4062DNA, residual host-cell, quantification and characterisation of(2.6.35.) .................................................................................... 248

Dobesilate monohydrate, calcium ........................................ 2048Dobutamine hydrochloride ................................................... 2452Docetaxel ................................................................................. 2453Docetaxel trihydrate ............................................................... 2455Docusate sodium .................................................................... 2457Dodecyl gallate........................................................................ 2457Dog rose................................................................................... 1415Domperidone .......................................................................... 2458Domperidone maleate............................................................ 2460Donepezil hydrochloride ..............................................10.1-4400Donepezil hydrochloride monohydrate......................10.1-4401Dopamine hydrochloride ...................................................... 2461Dopexamine dihydrochloride ............................................... 2463Dorzolamide hydrochloride .................................................. 2464Dosage forms (glossary) .......................................................... 905Dosage units, demonstration of uniformity using large samplesizes (2.9.47.) ........................................................................... 409

Dosage units, uniformity of (2.9.40.) ..................................... 398Dosulepin hydrochloride..............................................10.4-5467DOTATOC (gallium (68Ga)) injection ................................. 1208Doxapram hydrochloride ...................................................... 2467Doxazosin mesilate................................................................. 2468Doxepin hydrochloride .......................................................... 2470Doxorubicin hydrochloride................................................... 2471Doxycycline hyclate ................................................................ 2472Doxycycline monohydrate..................................................... 2474Doxylamine hydrogen succinate........................................... 2476Dronedarone hydrochloride.................................................. 2477Dronedarone tablets ......................................................10.3-4968Drop point (2.2.17.).................................................................... 33Droperidol ............................................................................... 2478Droppers (2.1.1.)......................................................................... 15Drops, nasal....................................................................10.3-4823Drops, oral ................................................................................. 918Drops, oromucosal ........................................................10.3-4827Drospirenone .......................................................................... 2480Dry extracts ............................................................................... 868Dry residue of extracts (2.8.16.).............................................. 311Drying, loss on (2.2.32.)............................................................. 57Drynaria rhizome ................................................................... 1416Duck plague vaccine (live)............................................10.2-4646Duck viral hepatitis type I vaccine (live) ....................10.2-4647Duloxetine hydrochloride...................................................... 2481Dutasteride .............................................................................. 2483Dwarf lilyturf tuber .......................................................10.1-4354Dwarf pine oil ......................................................................... 1419Dydrogesterone....................................................................... 2485

EEar drops and ear sprays.......................................................... 908Ear powders............................................................................... 909Ear preparations........................................................................ 908Ear preparations, semi-solid ................................................... 908Ear sprays and ear drops.......................................................... 908Ear tampons .............................................................................. 909Ear washes ................................................................................. 909Ebastine.................................................................................... 2489Eclipta herb ............................................................................. 1420Econazole................................................................................. 2490Econazole nitrate .................................................................... 2491Edetate (chromium (51Cr)) injection.................................... 1186Edetate, disodium................................................................... 2445Edetate, sodium calcium........................................................ 3807Edetic acid ............................................................................... 2492Edotreotide (gallium (68Ga)) injection................................. 1208Edrophonium chloride........................................................... 2493Effervescent granules ............................................................... 912Effervescent powders ............................................................... 927Effervescent tablets................................................................... 939

Efficacy of antimicrobial preservation (5.1.3.)...................... 625Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.) ...................................................................................... 661

Egg drop syndrome ‘76 vaccine (inactivated) ............10.2-4648Egg phospholipids for injection............................................ 2494Elder flower ............................................................................. 1421Electrochemical detection, pulsed, and direct amperometricdetection (2.2.63.) ................................................................... 117

Electrophoresis (2.2.31.) ............................................................ 51Electrophoresis, capillary (2.2.47.) ..............................10.1-4315Elemental impurities (5.20.).................................................... 815Elemental impurities, determination of (2.4.20.) ................. 144Eleutherococcus...................................................................... 1423Emedastine difumarate .......................................................... 2496Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.3.5.)..................... 473

Emulsifying cetostearyl alcohol (type A)............................. 2156Emulsifying cetostearyl alcohol (type B) ............................. 2157Emulsions, oromucosal .................................................10.3-4826Emulsions, solutions and suspensions, oral .......................... 917Enalapril maleate .................................................................... 2497Enalaprilat dihydrate.............................................................. 2499Encephalitis vaccine (inactivated), tick-borne.................... 1043Encephalomyelitis vaccine (live), infectious, avian ...10.2-4628Endotoxins, bacterial (2.6.14.) ................................................ 209Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .........................................................................10.3-4802

Endotoxins (bacterial) using recombinant factor C, test for(2.6.32.) .........................................................................10.3-4776

Enilconazole for veterinary use ............................................ 2500Enoxaparin sodium ................................................................ 2502Enoxolone ................................................................................ 2504Enrofloxacin for veterinary use............................................. 2505Entacapone .............................................................................. 2507Entecavir monohydrate.......................................................... 2508Enteric redmouth disease vaccine (inactivated) for rainbowtrout........................................................................................ 1102

Enumeration of microbial contaminants in live biotherapeuticproducts (2.6.36.).................................................................... 250

Enzootic pneumonia vaccine (inactivated), porcine.......... 1141Ephedra herb ........................................................................... 1425Ephedrine ................................................................................ 2510Ephedrine hemihydrate ......................................................... 2511Ephedrine hydrochloride....................................................... 2511Ephedrine hydrochloride, racemic ....................................... 2513Epinastine hydrochloride..............................................10.3-4973Epinephrine ....................................................................10.3-4901Epinephrine tartrate ............................................................... 1767Epirubicin hydrochloride .............................................10.3-4974Eplerenone............................................................................... 2516Eptacog alfa (activated) concentrated solution................... 2840Equine herpesvirus vaccine (inactivated)............................ 1103Equine influenza vaccine (inactivated) ................................ 1104Equisetum stem ...................................................................... 1426Ergocalciferol .......................................................................... 2518Ergoloid mesilates................................................................... 2290Ergometrine maleate .....................................................10.3-4975Ergotamine tartrate .......................................................10.3-4977Erysipelas vaccine (inactivated), swine................................ 1158Erythritol ................................................................................. 2522Erythromycin .................................................................10.4-5473Erythromycin estolate ............................................................ 2527Erythromycin ethylsuccinate................................................. 2531Erythromycin lactobionate .................................................... 2533Erythromycin stearate ............................................................ 2537Erythropoietin concentrated solution.................................. 2540Escitalopram............................................................................ 2544Escitalopram oxalate .....................................................10.1-4408Eserine salicylate..................................................................... 3554Esketamine hydrochloride..................................................... 2548Esomeprazole magnesium dihydrate ................................... 2549Esomeprazole magnesium trihydrate................................... 2551Esomeprazole sodium ............................................................ 2553



Essential oils .............................................................................. 864Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 307Essential oils, fatty oils and resinified essential oils in(2.8.7.) ...................................................................................... 306

Essential oils, foreign esters in (2.8.6.) ................................... 306Essential oils in herbal drugs (2.8.12.) ................................... 307Essential oils, odour and taste (2.8.8.) ................................... 306Essential oils, residue on evaporation (2.8.9.)....................... 306Essential oils, solubility in alcohol (2.8.10.) .......................... 306Essential oils, water in (2.8.5.)................................................. 306Ester value (2.5.2.) .................................................................... 167Estradiol benzoate .................................................................. 2555Estradiol hemihydrate............................................................ 2556Estradiol valerate .................................................................... 2557Estriol ....................................................................................... 2559Estrogens, conjugated............................................................. 2561Etacrynic acid.......................................................................... 2563Etamsylate................................................................................ 2565Etanercept .......................................................................10.3-4979Ethacridine lactate monohydrate.......................................... 2570Ethambutol hydrochloride .................................................... 2571Ethanol (96 per cent).............................................................. 2573Ethanol, anhydrous................................................................. 2575Ethanol content (2.9.10.) ......................................................... 339Ether ......................................................................................... 2577Ether, anaesthetic.................................................................... 2577Ethinylestradiol ....................................................................... 2578Ethionamide ............................................................................ 2580Ethosuximide .......................................................................... 2581Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ............................................................................... 163

Ethyl acetate ............................................................................ 2582Ethyl acrylate - methacrylic acid copolymer (1:1).............. 3214Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ............................................................................. 3216

Ethyl oleate .............................................................................. 2583Ethyl parahydroxybenzoate ................................................... 2583Ethyl parahydroxybenzoate sodium..................................... 3816Ethylcellulose........................................................................... 2585Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) .................................................................................... 163

Ethylene glycol monopalmitostearate .................................. 2586Ethylene glycol monostearate................................................ 2586Ethylene oxide and dioxan (2.4.25.) ....................................... 157Ethylenediamine ..................................................................... 2587Ethylhexanoic acid, 2- (2.4.28.)............................................... 160Ethylmorphine hydrochloride............................................... 2587Etidronate disodium............................................................... 2589Etilefrine hydrochloride......................................................... 2589Etodolac ................................................................................... 2591Etofenamate............................................................................. 2593Etomidate................................................................................. 2595Etoposide ................................................................................. 2596Eucalyptus leaf ........................................................................ 1428Eucalyptus oil .......................................................................... 1429Eucommia bark....................................................................... 1430Eugenol .................................................................................... 2599European goldenrod............................................................... 1460European viper venom antiserum ........................................ 1174Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.) ...................................................................................... 661

Evaluation of safety of each batch of immunosera forveterinary use (5.2.9.)............................................................. 673

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...................................................................................... 658

Evening primrose oil, refined................................................ 2601Everolimus ......................................................................10.3-4984Evodia fruit.............................................................................. 1431Excipients, functionality-related characteristics of (5.15.) .. 793Exemestane.....................................................................10.1-4410Extemporaneous preparation of radiopharmaceuticals(5.19.) ....................................................................................... 807

Extractable volume of parenteral preparations, test for(2.9.17.) .................................................................................... 347

Extracts, dry .............................................................................. 868Extracts, dry residue of (2.8.16.)............................................. 311Extracts, herbal drug ................................................................ 865Extracts, herbal drug, monographs on (information chapter)(5.23.) ....................................................................................... 843

Extracts, liquid (fluid) .............................................................. 867Extracts, loss on drying of (2.8.17.)........................................ 311Extracts, soft .............................................................................. 867Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological examination (2.6.31.) ........... 239

Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological quality (5.1.8.) ....................... 638

Extracts, water for preparation of......................................... 4206Extraneous agents in viral vaccines for human use, tests for(2.6.16.) .........................................................................10.2-4579

Extraneous viruses in immunological veterinary medicinalproducts - principles for the detection of, using culturemethods (2.6.37.) .........................................................10.3-4778

Eye drops ................................................................................... 909Eye lotions ................................................................................. 910Eye preparations ....................................................................... 909Eye preparations, semi-solid ................................................... 910

FF concepts to the heat sterilisation processes, application of(5.1.5.) ...........................................................................10.3-4802

Factor II, human coagulation, assay of (2.7.18.) ................... 288Factor IX, human coagulation .............................................. 2846Factor IX, human coagulation, assay of (2.7.11.).................. 281Factor IX (rDNA) concentrated solution, humancoagulation ...................................................................10.3-5007

Factor IX (rDNA) powder for solution for injection, humancoagulation ...................................................................10.3-5012

Factor VII, human coagulation............................................. 2838Factor VII, human coagulation, assay of (2.7.10.) ................ 280Factor VIIa (rDNA) concentrated solution, human coagulation................................................................................................ 2840

Factor VIII, human coagulation ........................................... 2844Factor VIII, human coagulation, assay of (2.7.4.) ................ 268Factor VIII (rDNA), human coagulation ............................ 2845Factor X, human coagulation, assay of (2.7.19.) ................... 289Factor XI, human coagulation .............................................. 2855Factor XI, human coagulation, assay of (2.7.22.) ................. 291Falling ball and automatic rolling ball viscometer methods(2.2.49.) .........................................................................10.3-4761

Famotidine............................................................................... 2609Fat, hard ................................................................................... 2811Fat, hard with additives.......................................................... 2812Fatty acids, composition by gas chromatography (2.4.22.).. 147Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) .................................................................................... 161

Fatty oils, alkaline impurities in (2.4.19.) .............................. 144Fatty oils and resinified essential oils in essential oils(2.8.7.) ...................................................................................... 306

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .................................................................................... 147

Fatty oils, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 132

Fatty oils, sterols in (2.4.23.).................................................... 150Fatty oils, vegetable................................................................... 901Fc function of immunoglobulin, test for (2.7.9.) .................. 279Febantel for veterinary use .................................................... 2610Feeding stuffs for veterinary use, medicated, premixes for.. 927Felbinac .................................................................................... 2611Feline calicivirosis vaccine (inactivated).............................. 1106Feline calicivirosis vaccine (live)..................................10.2-4650Feline chlamydiosis vaccine (inactivated) ........................... 1108Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .......................................................................... 1109



Feline infectious enteritis (feline panleucopenia) vaccine(live) ..............................................................................10.2-4651

Feline leukaemia vaccine (inactivated) ................................ 1112Feline panleucopenia vaccine (inactivated)......................... 1109Feline panleucopenia vaccine (live) ............................10.2-4651Feline viral rhinotracheitis vaccine (inactivated) ............... 1113Feline viral rhinotracheitis vaccine (live) ...................10.2-4652Felodipine ................................................................................ 2612Felypressin ............................................................................... 2614Fenbendazole for veterinary use........................................... 2615Fenbufen .................................................................................. 2616Fennel, bitter ........................................................................... 1433Fennel, sweet ........................................................................... 1434Fenofibrate............................................................................... 2617Fenoterol hydrobromide ........................................................ 2618Fentanyl.................................................................................... 2619Fentanyl citrate........................................................................ 2621Fenticonazole nitrate .............................................................. 2622Fenugreek ................................................................................ 1435Fermentation, products of ............................................10.4-5387Ferric chloride hexahydrate................................................... 2624Ferrous fumarate..................................................................... 2624Ferrous gluconate ................................................................... 2625Ferrous sulfate, dried.............................................................. 2626Ferrous sulfate heptahydrate ................................................. 2627Ferrum metallicum for homoeopathic preparations ......... 1714FET (18F) injection.................................................................. 1201Feverfew..........................................................................10.4-5404Fexofenadine hydrochloride.................................................. 2628Fibrin sealant kit ..................................................................... 2630Fibrinogen, human ................................................................. 2856Filgrastim concentrated solution.......................................... 2631Filgrastim injection ................................................................ 2634Films, buccal...................................................................10.3-4828Films, orodispersible .....................................................10.3-4828Finasteride ............................................................................... 2636Fineness, powder (2.9.35.) ....................................................... 387Fingolimod hydrochloride............................................10.3-4989Fipronil for veterinary use..................................................... 2639Fish oil, rich in omega-3 acids .............................................. 2639Flavoxate hydrochloride......................................................... 2642Flecainide acetate.................................................................... 2643Fleeceflower root..................................................................... 1437Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.)............................................ 295

Flow cytometry (2.7.24.).......................................................... 293Flowability (2.9.16.) .................................................................. 346FLT (18F) injection .................................................................. 1181Flubendazole ........................................................................... 2644Flucloxacillin magnesium octahydrate ................................ 2645Flucloxacillin sodium............................................................. 2647Fluconazole.............................................................................. 2649Flucytosine............................................................................... 2650Fludarabine phosphate........................................................... 2652Fludeoxyglucose (18F) injection ............................................ 1190Fludrocortisone acetate.......................................................... 2654Flumazenil ............................................................................... 2655Flumazenil (N-[11C]methyl) injection.................................. 1192Flumequine.............................................................................. 2657Flumetasone pivalate.............................................................. 2658Flunarizine dihydrochloride.................................................. 2659Flunitrazepam ......................................................................... 2660Flunixin meglumine for veterinary use ............................... 2661Fluocinolone acetonide.......................................................... 2662Fluocortolone pivalate...................................................10.1-4415Fluorescein .............................................................................. 2666Fluorescein sodium ................................................................ 2667Fluoride (18F) solution for radiolabelling............................. 1194Fluorides (2.4.5.) ....................................................................... 138Fluorimetry (2.2.21.) .................................................................. 36Fluorocholine (18F) injection................................................. 1195Fluorodeoxythymidine (18F) injection ................................. 1181

Fluorodopa (18F) (prepared by electrophilic substitution)injection ................................................................................. 1197

Fluorodopa (18F) (prepared by nucleophilic substitution)injection ................................................................................. 1198

Fluoroethyl-L-tyrosine (18F) injection .................................. 1201Fluoromisonidazole (18F) injection....................................... 1204Fluorouracil ............................................................................. 2669Fluoxetine hydrochloride..............................................10.3-4990Flupentixol dihydrochloride.................................................. 2672Fluphenazine decanoate................................................10.1-4416Fluphenazine dihydrochloride .............................................. 2675Fluphenazine enantate ..................................................10.3-4991Flurazepam monohydrochloride .......................................... 2679Flurbiprofen............................................................................. 2680Fluspirilene .............................................................................. 2681Flutamide................................................................................. 2682Fluticasone propionate..................................................10.4-5479Flutrimazole ............................................................................ 2685Fluvastatin sodium ................................................................. 2686Fluvoxamine maleate.............................................................. 2688FMISO (18F) injection ............................................................ 1204Foam index (2.8.24.)................................................................. 317Foams, cutaneous ..................................................................... 916Foams, intrauterine .................................................................. 914Foams, medicated ..................................................................... 911Foams, rectal ............................................................................. 935Foams, vaginal........................................................................... 941Folic acid hydrate.................................................................... 2690Folinate hydrate, calcium....................................................... 2049Follitropin................................................................................ 2691Follitropin concentrated solution ......................................... 2697Foot-and-mouth disease (ruminants) vaccine(inactivated) .......................................................................... 1115

Foreign esters in essential oils (2.8.6.).................................... 306Foreign matter (2.8.2.) ............................................................. 305Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .................................................................................... 147

Formaldehyde, free (2.4.18.).................................................... 143Formaldehyde solution (35 per cent) ................................... 2703Formic acid.............................................................................. 2703Formoterol fumarate dihydrate............................................. 2704Forsythia fruit ................................................................10.4-5406Foscarnet sodium hexahydrate ............................................. 2706Fosfomycin calcium................................................................ 2708Fosfomycin sodium ................................................................ 2709Fosfomycin trometamol......................................................... 2710Fosinopril sodium .................................................................. 2711Fourstamen stephania root.................................................... 1438Fowl cholera vaccine (inactivated) ....................................... 1117Fowl-pox vaccine (live) .................................................10.2-4653Framycetin sulfate .................................................................. 2714Frangula bark .......................................................................... 1439Frangula bark dry extract, standardised.............................. 1441Frankincense, Indian.............................................................. 1480Fraxinus chinensis bark ................................................10.1-4356Free formaldehyde (2.4.18.)..................................................... 143Freezing point (2.2.18.) .............................................................. 35Fresh bilberry fruit dry extract, refined and standardised.. 1442Friability of granules and spheroids (2.9.41.)........................ 400Friability of uncoated tablets (2.9.7.) ..................................... 336Fructose.................................................................................... 2715Fucus ........................................................................................ 1494Fulvestrant ............................................................................... 2716Fumitory .................................................................................. 1444Functional groups and ions, identification reactions of(2.3.1.) ...................................................................................... 129

Functionality-related characteristics of excipients (5.15.) ... 793Fungicidal, bactericidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) .................. 643

Furosemide .............................................................................. 2718Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids......................................................................... 1119

Fusidate, sodium..................................................................... 3818



Fusidic acid.............................................................................. 2719

GGabapentin .............................................................................. 2725Gadobutrol monohydrate .............................................10.4-5485Gadodiamide hydrate............................................................. 2728Galactose.................................................................................. 2730Galantamine hydrobromide .........................................10.3-4997Gallium (67Ga) citrate injection ............................................ 1206Gallium (68Ga) chloride (accelerator-produced) solution forradiolabelling ...............................................................10.3-4864

Gallium (68Ga) chloride solution for radiolabelling ........... 1206Gallium (68Ga) DOTATOC injection ................................... 1208Gallium (68Ga) edotreotide injection ................................... 1208Gallium (68Ga) PSMA-11 injection .............................10.4-5397Gammacyclodextrin ......................................................10.1-4423Gammadex .....................................................................10.1-4423Ganciclovir .............................................................................. 2735Ganoderma.....................................................................10.3-4876Gargles ............................................................................10.3-4826Garlic for homoeopathic preparations................................. 1701Garlic powder.......................................................................... 1446Gas adsorption, specific surface area by (2.9.26.)................. 369Gas chromatography (2.2.28.) ................................................... 48Gas detector tubes (2.1.6.) ......................................................... 17Gas pycnometric density of solids (2.9.23.)........................... 364Gases, carbon dioxide in (2.5.24.) .......................................... 174Gases, carbon monoxide in (2.5.25.)...................................... 175Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) .................................................................................... 176

Gases, nitrous oxide in (2.5.35.) ............................................. 182Gases, oxygen in (2.5.27.) ........................................................ 176Gases, water in (2.5.28.) ........................................................... 176Gas-gangrene antitoxin, mixed............................................. 1170Gas-gangrene antitoxin (novyi) ............................................ 1171Gas-gangrene antitoxin (perfringens).................................. 1171Gas-gangrene antitoxin (septicum)...................................... 1172Gastrodia rhizome.................................................................. 1447Gastro-resistant capsules ......................................................... 907Gastro-resistant granules ......................................................... 913Gastro-resistant tablets ............................................................ 938Gefitinib ................................................................................... 2737Gelatin.............................................................................10.4-5486Gels ............................................................................................. 936Gels for injections..................................................................... 925Gemcitabine hydrochloride................................................... 2739Gemfibrozil.............................................................................. 2740Gene transfer medicinal products for human use (5.14.).... 779General notices (1.) ...................................................................... 3General texts on biological products (5.2.) ........................... 647General texts on microbiology (5.1.) ..................................... 619Genetically modified cells........................................................ 779Gentamicin sulfate.........................................................10.3-4999Gentian root ............................................................................ 1448Gentian tincture...................................................................... 1449Gestodene ................................................................................ 2744Ginger ...................................................................................... 1450Gingival preparations....................................................10.3-4825Ginkgo dry extract, refined and quantified......................... 1451Ginkgo leaf .............................................................................. 1454Ginseng .................................................................................... 1455Ginseng dry extract ................................................................ 1457Glass containers for pharmaceutical use (3.2.1.) .................. 453Glibenclamide ......................................................................... 2746Gliclazide ................................................................................. 2747Glimepiride ............................................................................. 2749Glipizide................................................................................... 2751Glossary (dosage forms) .......................................................... 905Glucagon, human ................................................................... 2753Glucoheptonate, calcium ....................................................... 2051Glucosamine hydrochloride .................................................. 2754Glucosamine sulfate potassium chloride ............................. 2755

Glucosamine sulfate sodium chloride.................................. 2757Glucose..................................................................................... 2758Glucose, liquid ........................................................................ 2759Glucose, liquid, spray-dried .................................................. 2760Glucose monohydrate ............................................................ 2761Glutamic acid .......................................................................... 2762Glutathione.............................................................................. 2763Glycan analysis of glycoproteins (2.2.59.) ............................. 109Glycerol .................................................................................... 2765Glycerol (85 per cent)............................................................. 2766Glycerol dibehenate................................................................ 2767Glycerol distearate .................................................................. 2768Glycerol formal ....................................................................... 2769Glycerol monocaprylate......................................................... 2770Glycerol monocaprylocaprate ............................................... 2771Glycerol monolinoleate.......................................................... 2772Glycerol mono-oleate ............................................................. 2773Glycerol monostearate 40-55 ................................................ 2774Glycerol triacetate................................................................... 4083Glyceryl trinitrate solution .................................................... 2775Glycine ............................................................................10.3-5001Glycoproteins, glycan analysis of (2.2.59.) ............................ 109Glycopyrronium bromide...................................................... 2779Glycyrrhizate ammonium...................................................... 1833Goldenrod................................................................................ 1458Goldenrod, European............................................................. 1460Goldenseal rhizome................................................................ 1461Gonadorelin acetate................................................................ 2781Gonadotrophin, chorionic..................................................... 2782Gonadotrophin, equine serum, for veterinary use............. 2783Goserelin.................................................................................. 2783Grafted copolymer, macrogol poly(vinyl alcohol) ............. 3140Gramicidin .............................................................................. 2785Granisetron hydrochloride.................................................... 2787Granules..................................................................................... 912Granules and powders for oral solutions and suspensions.. 917Granules and powders for syrups ........................................... 918Granules and spheroids, friability of (2.9.41.)....................... 400Granules, coated ....................................................................... 912Granules, effervescent .............................................................. 912Granules, gastro-resistant ........................................................ 913Granules, modified-release...................................................... 912Greater celandine.................................................................... 1463Green tea.................................................................................. 1464Griseofulvin............................................................................. 2788Guaiacol ................................................................................... 2789Guaifenesin.............................................................................. 2791Guanethidine monosulfate .................................................... 2792Guar.......................................................................................... 1466Guar galactomannan .............................................................. 2793Guarana.................................................................................... 1467Guidelines for using the test for bacterial endotoxins(5.1.10.) .........................................................................10.3-4802

Guidelines for using the test for sterility (5.1.9.) .................. 639

HHaemagglutinins, anti-A and anti-B (2.6.20.)....................... 218Haematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.) ............................................................................... 292

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) .................................................................... 296

Haematopoietic stem cells, human....................................... 2857Haemodiafiltration and haemofiltration, concentratedsolutions for........................................................................... 2801

Haemodiafiltration and haemofiltration, solutions for...... 2803Haemodialysis, concentrated solutions for ......................... 2798Haemodialysis solutions, concentrated, water fordiluting................................................................................... 2797

Haemodialysis, solutions for ................................................. 2798Haemofiltration and haemodiafiltration, concentratedsolutions for........................................................................... 2801

Haemofiltration and haemodiafiltration, solutions for...... 2803



Haemophilus type b and meningococcal group C conjugatevaccine ..................................................................................... 979

Haemophilus type b (conjugate), diphtheria, tetanusand pertussis (acellular, component) vaccine(adsorbed) ....................................................................10.3-4839

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated)vaccine (adsorbed) ......................................................10.3-4849

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) ...............................10.3-4846

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (whole cell) and poliomyelitis (inactivated) vaccine(adsorbed) ....................................................................10.3-4853

Haemophilus type b conjugate vaccine.................................. 980Haemorrhagic disease vaccine (inactivated), rabbit ..10.2-4665Halofantrine hydrochloride................................................... 2805Haloperidol.............................................................................. 2806Haloperidol decanoate ........................................................... 2808Halothane ................................................................................ 2809Hamamelis bark...................................................................... 1468Hamamelis leaf........................................................................ 1469Hard capsules ............................................................................ 906Hard fat .................................................................................... 2811Hard fat with additives........................................................... 2812Hard paraffin........................................................................... 3483Harmonisation, pharmacopoeial (5.8.).................................. 755Hawthorn berries...........................................................10.1-4357Hawthorn leaf and flower .............................................10.3-4877Hawthorn leaf and flower dry extract .........................10.3-4880Hawthorn leaf and flower liquid extract.....................10.3-4882HCP assays (2.6.34.) ................................................................. 244Healthy chicken flocks for the production of inactivatedvaccines for veterinary use (5.2.13.)..........................10.2-4598

Heat sterilisation, application of the F concepts(5.1.5.) ...........................................................................10.3-4802

Heavy bismuth subnitrate...................................................... 1985Heavy kaolin............................................................................ 3031Heavy magnesium carbonate ................................................ 3153Heavy magnesium oxide...............................................10.3-5062Heavy metals (2.4.8.) ................................................................ 139Heavy metals in herbal drugs and herbal drug preparations(2.4.27.) .................................................................................... 158

Hedera helix for homoeopathic preparations ..................... 1715Helium ..................................................................................... 2814Heparin, assay of (2.7.5.) ......................................................... 269Heparin calcium ..................................................................... 2814Heparin in coagulation factors, assay of (2.7.12.)................. 281Heparin sodium...................................................................... 2816Heparins, low-molecular-mass ............................................. 2818Hepatitis A immunoglobulin, human.................................. 2858Hepatitis A (inactivated, adsorbed) and typhoid polysaccharidevaccine ..................................................................................... 982

Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 983

Hepatitis A vaccine, assay of (2.7.14.) .........................10.3-4781Hepatitis A vaccine (inactivated, adsorbed).......................... 984Hepatitis A vaccine (inactivated, virosome).......................... 985Hepatitis B immunoglobulin for intravenous administration,human .................................................................................... 2859

Hepatitis B immunoglobulin, human .................................. 2858Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed) ....................................................................10.3-4832

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ..............10.3-4841

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) .........................10.3-4846

Hepatitis B vaccine (rDNA) .................................................... 988Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 285Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : guidelines ....................................................... 219

Hepatitis type I vaccine (live), viral, duck ..................10.2-4647Heptaminol hydrochloride .................................................... 2821Herbal drug extracts................................................................. 865Herbal drug extracts, monographs on (information chapter)(5.23.) ....................................................................................... 843

Herbal drug preparations ........................................................ 869Herbal drugs.............................................................................. 869Herbal drugs and herbal drug preparations, heavy metals in(2.4.27.) .................................................................................... 158

Herbal drugs and herbal drug preparations, high-performancethin-layer chromatography of (2.8.25.)................................ 318

Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 311Herbal drugs, essential oils in (2.8.12.).................................. 307Herbal drugs for homoeopathic preparations..................... 1680Herbal drugs : introduction ................................................... 1289Herbal drugs, microscopic examination of (2.8.23)............. 317Herbal drugs : sampling and sample preparation (2.8.20.).. 313Herbal drugs, tannins in (2.8.14.)........................................... 310Herbal drugs, test for aristolochic acids in (2.8.21) ............. 314Herbal medicinal products for oral use and extracts used intheir preparation, microbiological examination (2.6.31.).. 239

Herbal medicinal products for oral use and extracts used intheir preparation, microbiological quality (5.1.8.) ............. 638

Herbal preparations.................................................................. 869Herbal substances ..................................................................... 869Herbal teas................................................................................. 870Herbal teas, instant................................................................... 871Herpes zoster (shingles) vaccine (live)................................. 1036Herpesvirus vaccine (inactivated), equine........................... 1103Hexamidine diisetionate ........................................................ 2822Hexetidine ............................................................................... 2823Hexosamines in polysaccharide vaccines (2.5.20.) ............... 173Hexylresorcinol ....................................................................... 2824High-molecular-mass macrogols.......................................... 3147High-performance thin-layer chromatography of herbal drugsand herbal drug preparations (2.8.25.) ................................ 318

Histamine (2.6.10.) ................................................................... 200Histamine dihydrochloride ................................................... 2825Histaminum for homoeopathic preparations ..................... 1716Histidine .................................................................................. 2826Histidine hydrochloride monohydrate ................................ 2827Homatropine hydrobromide ................................................. 2829Homatropine methylbromide ............................................... 2830Homoeopathic pillules, coated.............................................. 1697Homoeopathic pillules, impregnated ................................... 1697Homoeopathic preparations.........................................10.3-4893Homoeopathic preparations, acidum picrinicum for ........ 1698Homoeopathic preparations, acidum succinicum for........ 1698Homoeopathic preparations, Adonis vernalis for .....10.1-4369Homoeopathic preparations, Agaricus phalloides for ....... 1699Homoeopathic preparations, Allium sativum for .............. 1701Homoeopathic preparations, ammonium carbonicumfor ........................................................................................... 1701

Homoeopathic preparations, Anacardium for.................... 1702Homoeopathic preparations, Apis for.................................. 1703Homoeopathic preparations, arsenicum album for ........... 1704Homoeopathic preparations, aurum chloratum natronatumfor .......................................................................................... 1704

Homoeopathic preparations, barium chloratum for.......... 1705Homoeopathic preparations, Belladonna for...................... 1705Homoeopathic preparations, cadmium sulfuricum for..... 1707Homoeopathic preparations, calcium fluoratum for ......... 1707Homoeopathic preparations, calcium iodatum for ............ 1708Homoeopathic preparations, Cocculus for ......................... 1708Homoeopathic preparations, Crocus for ............................. 1710Homoeopathic preparations, cuprum aceticum for........... 1711Homoeopathic preparations, cuprum metallicum for....... 1712Homoeopathic preparations, digitalis for ........................... 1712Homoeopathic preparations, ferrum metallicum for ........ 1714Homoeopathic preparations, hedera helix for .................... 1715Homoeopathic preparations, herbal drugs for.................... 1680Homoeopathic preparations, histaminum for .................... 1716Homoeopathic preparations, hydrastis canadensis for ...... 1716



Homoeopathic preparations, hyoscyamus for .................... 1717Homoeopathic preparations, hypericum for....................... 1718Homoeopathic preparations : introduction ......................... 1679Homoeopathic preparations, kalium bichromicum for..... 1721Homoeopathic preparations, magnesium fluoratumfor ..................................................................................10.1-4370

Homoeopathic preparations, magnesium phosphoricumfor ........................................................................................... 1722

Homoeopathic preparations, mother tinctures for ............ 1681Homoeopathic preparations, Nux-vomica for .................... 1723Homoeopathic preparations, petroleum rectificatum for.. 1725Homoeopathic preparations, pillules for ....................10.3-4894Homoeopathic preparations, selenium for.......................... 1725Homoeopathic preparations, Staphysagria for.................... 1726Homoeopathic preparations, sulfur for ............................... 1727Homoeopathic preparations, Urtica dioica for ................... 1728Homoeopathic stocks (methods of preparation of) andpotentisation ......................................................................... 1682

Homoepathic preparations, Ignatia for................................ 1719Honey ....................................................................................... 2831Honey bee for homoeopathic preparations......................... 1703Hop strobile............................................................................. 1474Horse-chestnut ........................................................................ 1475Horse-chestnut dry extract, standardised............................ 1477Host-cell DNA, residual, quantification and characterisationof (2.6.35.)................................................................................ 248

Host-cell protein assays (2.6.34.) ............................................ 244Houttuynia herb...................................................................... 1478Human α-1-proteinase inhibitor .......................................... 2869Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 300Human albumin injection, iodinated (125I) ......................... 1210Human albumin solution ...................................................... 2832Human anti-D immunoglobulin .......................................... 2834Human anti-D immunoglobulin, assay of (2.7.13.) ............. 282Human anti-D immunoglobulin for intravenousadministration....................................................................... 2835

Human antithrombin III, assay of (2.7.17.)........................... 288Human antithrombin III concentrate .................................. 2835Human C1-esterase inhibitor................................................ 2837Human C1-esterase inhibitor, assay of (2.7.34.) ................... 301Human coagulation factor II, assay of (2.7.18.) .................... 288Human coagulation factor IX ............................................... 2846Human coagulation factor IX, assay of (2.7.11.)................... 281Human coagulation factor IX (rDNA) concentratedsolution .........................................................................10.3-5007

Human coagulation factor IX (rDNA) powder for solution forinjection ........................................................................10.3-5012

Human coagulation factor VII.............................................. 2838Human coagulation factor VII, assay of (2.7.10.) ................. 280Human coagulation factor VIIa (rDNA) concentratedsolution .................................................................................. 2840

Human coagulation factor VIII ............................................ 2844Human coagulation factor VIII, assay of (2.7.4.) ................. 268Human coagulation factor VIII (rDNA) ............................. 2845Human coagulation factor X, assay of (2.7.19.) .................... 289Human coagulation factor XI ............................................... 2855Human coagulation factor XI, assay of (2.7.22.) .................. 291Human fibrinogen .................................................................. 2856Human glucagon..................................................................... 2753Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) .................................................................... 296

Human haematopoietic stem cells........................................ 2857Human hepatitis A immunoglobulin ................................... 2858Human hepatitis B immunoglobulin ................................... 2858Human hepatitis B immunoglobulin for intravenousadministration....................................................................... 2859

Human insulin ........................................................................ 2951Human measles immunoglobulin ........................................ 2859Human normal immunoglobulin for intramuscularadministration....................................................................... 2860

Human normal immunoglobulin for intravenousadministration....................................................................... 2862

Human normal immunoglobulin for subcutaneousadministration....................................................................... 2864

Human papillomavirus vaccine (rDNA) ............................... 989Human plasma for fractionation .......................................... 2865Human plasma (pooled and treated for virusinactivation) .......................................................................... 2867

Human plasmin inhibitor, assay of (2.7.25.) ......................... 295Human protein C, assay of (2.7.30.)....................................... 299Human protein S, assay of (2.7.31.)........................................ 300Human prothrombin complex .............................................. 2870Human rabies immunoglobulin ........................................... 2871Human rubella immunoglobulin ......................................... 2872Human tetanus immunoglobulin ......................................... 2873Human varicella immunoglobulin ....................................... 2875Human varicella immunoglobulin for intravenousadministration....................................................................... 2875

Human von Willebrand factor .............................................. 2875Human von Willebrand factor, assay of (2.7.21.) ................. 290Hyaluronate, sodium.............................................................. 3821Hyaluronidase ........................................................................ 2877Hydralazine hydrochloride.................................................... 2878Hydrastis canadensis for homoeopathic preparations ....... 1716Hydrochloric acid, concentrated .......................................... 2879Hydrochloric acid, dilute ....................................................... 2879Hydrochlorothiazide .............................................................. 2879Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2881Hydrocortisone ....................................................................... 2883Hydrocortisone acetate .......................................................... 2886Hydrocortisone hydrogen succinate..................................... 2888Hydrogen peroxide solution (3 per cent)............................. 2889Hydrogen peroxide solution (30 per cent)........................... 2890Hydrogenated arachis oil ....................................................... 1869Hydrogenated castor oil ................................................10.1-4389Hydrogenated cottonseed oil................................................. 2317Hydrogenated soya-bean oil.................................................. 3872Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 163Hydrogenated wool fat........................................................... 4215Hydromorphone hydrochloride............................................ 2890Hydrophobic colloidal silica.................................................. 3789Hydrous wool fat .................................................................... 4216Hydroxocobalamin acetate .................................................... 2892Hydroxocobalamin chloride.................................................. 2893Hydroxocobalamin sulfate..................................................... 2894Hydroxycarbamide ................................................................. 2895Hydroxychloroquine sulfate .................................................. 2896Hydroxyethyl salicylate .......................................................... 2897Hydroxyethyl starches ............................................................ 3892Hydroxyethylcellulose ............................................................ 2898Hydroxyethylmethylcellulose ................................................ 3237Hydroxyl value (2.5.3.)............................................................. 167Hydroxypropyl starch............................................................. 3888Hydroxypropyl starch, pregelatinised .................................. 3890Hydroxypropylbetadex........................................................... 2901Hydroxypropylcellulose ......................................................... 2903Hydroxypropylcellulose, low-substituted ............................ 2904Hydroxypropylmethylcellulose ............................................. 2914Hydroxypropylmethylcellulose phthalate ...................10.4-5491Hydroxyzine hydrochloride................................................... 2906Hymecromone......................................................................... 2907Hymenoptera venoms for allergen products....................... 2908Hyoscine .................................................................................. 2909Hyoscine butylbromide.......................................................... 2910Hyoscine hydrobromide ........................................................ 2911Hyoscyamine sulfate............................................................... 2913Hyoscyamus for homoeopathic preparations ..................... 1717Hypericum............................................................................... 1631Hypericum for homoeopathic preparations........................ 1718Hypromellose .......................................................................... 2914Hypromellose phthalate ................................................10.4-5491

IIbuprofen ................................................................................. 2921



Iceland moss............................................................................ 1480ICH (5.8.)................................................................................... 755Ichthammol ............................................................................. 2923Identification (2.3.) ................................................................... 129Identification and control of residual solvents(2.4.24.) .........................................................................10.1-4323

Identification of fatty oils by thin-layer chromatography(2.3.2.) ...................................................................................... 132

Identification of phenothiazines by thin-layer chromatography(2.3.3.) ...................................................................................... 133

Identification reactions of ions and functional groups(2.3.1.) ...................................................................................... 129

Idoxuridine .............................................................................. 2924Ifosfamide ................................................................................ 2925Ignatia for homoeopathic preparations ............................... 1719Imatinib mesilate .................................................................... 2926Imidacloprid for veterinary use ............................................ 2929Imipenem monohydrate ........................................................ 2930Imipramine hydrochloride .................................................... 2931Immunochemical methods (2.7.1.) ........................................ 261Immunoglobulin for human use, anti-T lymphocyte,animal .................................................................................... 1858

Immunoglobulin for intramuscular administration, humannormal.................................................................................... 2860

Immunoglobulin for intravenous administration, humananti-D ..................................................................................... 2835

Immunoglobulin for intravenous administration, humanhepatitis B .............................................................................. 2859

Immunoglobulin for intravenous administration, humannormal.................................................................................... 2862

Immunoglobulin for intravenous administration, humanvaricella .................................................................................. 2875

Immunoglobulin for subcutaneous administration, humannormal.................................................................................... 2864

Immunoglobulin, human anti-D.......................................... 2834Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 282Immunoglobulin, human hepatitis A................................... 2858Immunoglobulin, human hepatitis B ................................... 2858Immunoglobulin, human measles ........................................ 2859Immunoglobulin, human rabies ........................................... 2871Immunoglobulin, human rubella ......................................... 2872Immunoglobulin, human tetanus......................................... 2873Immunoglobulin, human varicella ....................................... 2875Immunoglobulin, test for anticomplementary activity of(2.6.17.) .................................................................................... 216

Immunoglobulin, test for Fc function of (2.7.9.).................. 279Immunonephelometry for vaccine component assay(2.7.35.) .................................................................................... 301

Immunosera and vaccines, phenol in (2.5.15.) ..................... 172Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 661

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 658

Immunosera for human use, animal ...........................10.4-5385Immunosera for veterinary use....................................10.2-4601Immunosera for veterinary use, evaluation of the safety ofeach batch (5.2.9.)................................................................... 673

Implants ..................................................................................... 925Impurities, elemental, determination of (2.4.20.)................. 144Impurities in substances for pharmaceutical use, control of(5.10.) ....................................................................................... 763

In vitro method(s) for the quality control of vaccines,substitution of in vivo method(s) by (5.2.14.)..................... 679

In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .................................................................................... 289

Inactivated vaccines for veterinary use, healthy chicken flocksfor the production of (5.2.13.) ...................................10.2-4598

Indapamide.....................................................................10.3-5017Index, foam (2.8.24.) ................................................................ 317Indian frankincense................................................................ 1480Indicators, approximate pH of solutions (2.2.4.) .................... 25Indigo plant leaf ...................................................................... 1481Indinavir sulfate ...................................................................... 2934

Indium (111In) chloride solution ........................................... 1211Indium (111In) oxine solution ................................................ 1212Indium (111In) pentetate injection ........................................ 1213Indometacin ............................................................................ 2936Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .................................................................................... 106

Inductively coupled plasma-mass spectrometry (2.2.58.) ... 108Infectious bovine rhinotracheitis vaccine (inactivated)..... 1120Infectious bovine rhinotracheitis vaccine (live).........10.2-4654Infectious bronchitis vaccine (inactivated), avian .....10.2-4622Infectious bronchitis vaccine (live), avian ..................10.2-4623Infectious bursal disease vaccine (inactivated),avian ..............................................................................10.2-4625

Infectious bursal disease vaccine (live), avian............10.2-4627Infectious chicken anaemia vaccine (live) ..................10.2-4655Infectious encephalomyelitis vaccine (live), avian.....10.2-4628Infectious enteritis vaccine (inactivated), feline ................. 1109Infectious enteritis vaccine (live), feline .....................10.2-4651Infectious laryngotracheitis vaccine (live), avian ......10.2-4630Infectious pancreatic necrosis vaccine (inactivated,oil-adjuvanted, injectable) for salmonids .......................... 1124

Infectious rhinotracheitis vaccine (live), turkey ........10.2-4668Infliximab concentrated solution.................................10.3-5019Influenza vaccine (inactivated), equine ............................... 1104Influenza vaccine (inactivated), porcine.............................. 1142Influenza vaccine (live, nasal) ......................................10.2-4611Influenza vaccine (split virion, inactivated) .......................... 995Influenza vaccine (surface antigen, inactivated)................... 996Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ............................................................................ 998

Influenza vaccine (surface antigen, inactivated,virosome)............................................................................... 1000

Influenza vaccine (whole virion, inactivated) ..................... 1002Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ................................................................................. 1003

Infrared absorption spectrophotometry (2.2.24.)......10.3-4753Infusions .................................................................................... 924Inhalation gas, krypton (81mKr)............................................. 1217Inhalation powders................................................................... 931Inhalation, preparations for .................................................... 927Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 347

Injectable insulin preparations.....................................10.4-5496Injections ................................................................................... 923Injections, gels for..................................................................... 925Injections or infusions, concentrates for ............................... 924Injections or infusions, powders for....................................... 924Inositol, myo- .................................................................10.4-5495Inserts, ophthalmic................................................................... 910Instant herbal teas .................................................................... 871Insulin aspart........................................................................... 2945Insulin glargine ....................................................................... 2949Insulin, human........................................................................ 2951Insulin injection, biphasic isophane..................................... 2953Insulin injection, isophane ...........................................10.4-5495Insulin injection, soluble ..............................................10.4-5496Insulin lispro ........................................................................... 2954Insulin, porcine ....................................................................... 2957Insulin preparations, injectable....................................10.4-5496Insulin zinc injectable suspension ...............................10.4-5499Insulin zinc injectable suspension (amorphous) .......10.4-5499Insulin zinc injectable suspension (crystalline) .........10.4-5499Interferon alfa-2 concentrated solution ............................... 2963Interferon beta-1a concentrated solution ............................ 2965Interferon gamma-1b concentrated solution ...................... 2968Interferons, assay of (5.6.)........................................................ 741International System (SI) units (1.) ............................................ 3Intramammary preparations for veterinary use ................... 913Intraruminal delivery systems ................................................ 913Intrauterine capsules ................................................................ 914Intrauterine foams .................................................................... 914Intrauterine preparations for veterinary use ......................... 914Intrauterine solutions, suspensions ........................................ 914



Intrauterine sticks ..................................................................... 914Intrauterine tablets ................................................................... 914Intrinsic dissolution (2.9.29.) .................................................. 372Iobenguane (123I) injection .................................................... 1213Iobenguane (131I) injection for diagnostic use..................... 1214Iobenguane (131I) injection for therapeutic use................... 1215Iobenguane sulfate for radiopharmaceutical prepara-tions........................................................................................ 1216

Iodinated (125I) human albumin injection ........................... 1210Iodinated povidone ................................................................ 3615Iodine ....................................................................................... 2971Iodine value (2.5.4.).................................................................. 167Iodixanol .................................................................................. 2971Iodohippurate (sodium) dihydrate for radiopharmaceuticalpreparations .......................................................................... 1234

Iodomethylnorcholesterol (131I) injection............................ 1217Iohexol...................................................................................... 2974Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 64

Ions and functional groups, identification reactions of(2.3.1.) ...................................................................................... 129

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 64

Iopamidol................................................................................. 2978Iopanoic acid ........................................................................... 2980Iopromide ................................................................................ 2981Iotrolan .................................................................................... 2984Ioxaglic acid............................................................................. 2986Ipecacuanha liquid extract, standardised ............................ 1483Ipecacuanha, prepared ........................................................... 1483Ipecacuanha root .................................................................... 1485Ipecacuanha tincture, standardised...................................... 1486Ipratropium bromide ............................................................. 2988Irbesartan................................................................................. 2990Irinotecan hydrochloride trihydrate............................10.1-4429Iron (2.4.9.)................................................................................ 142Iron for homoeopathic preparations.................................... 1714Irrigation, preparations for...................................................... 932Isatis root ................................................................................. 1487Isoconazole .....................................................................10.3-5024Isoconazole nitrate.........................................................10.3-5025Isoelectric focusing (2.2.54.) ..................................................... 95Isoflurane ................................................................................. 2996Isoleucine................................................................................. 2997Isomalt ..................................................................................... 2998Isoniazid................................................................................... 3000Isophane insulin injection ............................................10.4-5495Isoprenaline hydrochloride ..........................................10.1-4431Isoprenaline sulfate................................................................. 3002Isopropyl alcohol .................................................................... 3003Isopropyl isostearate............................................................... 3004Isopropyl myristate................................................................. 3004Isopropyl palmitate................................................................. 3005Isosorbide dinitrate, diluted ........................................10.1-4432Isosorbide mononitrate, diluted .................................10.1-4434Isotherms (sorption-desorption) and water activity,determination of (water-solid interactions) (2.9.39.)......... 394

Isotretinoin .............................................................................. 3009Isoxsuprine hydrochloride..................................................... 3010Ispaghula husk ........................................................................ 1488Ispaghula seed ......................................................................... 1489Isradipine ................................................................................. 3012Itraconazole ............................................................................. 3013Ivermectin................................................................................ 3015Ivy leaf ...................................................................................... 1489

JJava tea ..................................................................................... 1491Javanese turmeric.................................................................... 1652Josamycin........................................................................10.3-5029Josamycin propionate....................................................10.3-5031Juniper...................................................................................... 1492

Juniper oil ................................................................................ 1493

KKalium bichromicum for homoeopathic preparations ...... 1721Kanamycin acid sulfate .......................................................... 3029Kanamycin monosulfate ........................................................ 3030Kaolin, heavy........................................................................... 3031Kelp........................................................................................... 1494Ketamine hydrochloride ........................................................ 3031Ketobemidone hydrochloride ............................................... 3032Ketoconazole ..................................................................10.3-5037Ketoprofen ............................................................................... 3035Ketorolac trometamol ............................................................ 3037Ketotifen hydrogen fumarate ................................................ 3038Knotgrass ................................................................................. 1495Krypton (81mKr) inhalation gas ............................................. 1217Kudzuvine root ....................................................................... 1496Kudzuvine root, Thomson..................................................... 1644

LLabetalol hydrochloride................................................10.3-5041Lacosamide.............................................................................. 3045Lacosamide infusion .....................................................10.3-5043Lacosamide oral solution..............................................10.3-5044Lacosamide tablets.........................................................10.3-5045Lactic acid................................................................................ 3050Lactic acid, (S)- ....................................................................... 3051Lactitol monohydrate ....................................................10.3-5046Lactobionic acid...................................................................... 3053Lactose ............................................................................10.3-5048Lactose monohydrate ....................................................10.3-5049Lactulose .................................................................................. 3056Lactulose, liquid...................................................................... 3058Lamivudine.............................................................................. 3060Lamotrigine ............................................................................. 3063Lansoprazole ........................................................................... 3064Largehead atractylodes rhizome ........................................... 1328Laryngotracheitis vaccine (live), infectious, avian ....10.2-4630Laser light diffraction, particle size analysis by (2.9.31.) .... 373Latanoprost.....................................................................10.3-5050Laurilsulfate, sodium.....................................................10.3-5134Lauromacrogol 400................................................................. 3065Lauroyl macrogolglycerides................................................... 3068Lavender flower ...................................................................... 1497Lavender oil ............................................................................. 1499Lavender oil, spike.................................................................. 1630Lead in sugars (2.4.10.) ............................................................ 142Leflunomide ............................................................................ 3069Lemon oil................................................................................. 1500Lemon verbena leaf ................................................................ 1502Leptospirosis vaccine (inactivated), bovine......................... 1071Leptospirosis vaccine (inactivated), canine ......................... 1082Letrozole .........................................................................10.3-5052Leucine..................................................................................... 3071Leukaemia vaccine (inactivated), feline............................... 1112Leuprorelin .............................................................................. 3073Levamisole for veterinary use ............................................... 3074Levamisole hydrochloride ..................................................... 3075Levetiracetam.......................................................................... 3077Levocabastine hydrochloride .......................................10.3-5053Levocarnitine..................................................................10.1-4439Levodopa ................................................................................. 3082Levodropropizine.................................................................... 3083Levofloxacin hemihydrate ..................................................... 3085Levofolinate hydrate, calcium ............................................... 2060Levomenthol............................................................................ 3086Levomepromazine hydrochloride................................10.4-5503Levomepromazine maleate.................................................... 3088Levomethadone hydrochloride ............................................. 3089Levonorgestrel................................................................10.1-4440Levothyroxine sodium ........................................................... 3094Levulinate dihydrate, calcium ............................................... 2062



Lidocaine ................................................................................. 3095Lidocaine hydrochloride monohydrate ............................... 3097Light liquid paraffin ............................................................... 3483Light magnesium carbonate .................................................. 3153Light magnesium oxide.................................................10.3-5062Lightyellow sophora root....................................................... 1503Ligusticum root and rhizome ............................................... 1505Lime flower.....................................................................10.3-4883Limit tests (2.4.) ........................................................................ 137Limit tests, standard solutions for (4.1.2.) ..................10.4-5349Lincomycin hydrochloride .................................................... 3098Linen thread, sterile, in distributor for veterinary use ..... 1282Linoleoyl macrogolglycerides................................................ 3100Linseed ..................................................................................... 1507Linseed oil, virgin ................................................................... 3101Liothyronine sodium.............................................................. 3101Lipophilic solid dosage forms, dissolution test for(2.9.42.) .................................................................................... 401

Liquid chromatography (2.2.29.) .................................10.3-4757Liquid extraction preparations ............................................... 867Liquid (fluid) extracts .............................................................. 867Liquid glucose ......................................................................... 2759Liquid glucose, spray-dried ................................................... 2760Liquid lactulose....................................................................... 3058Liquid maltitol ........................................................................ 3171Liquid paraffin ........................................................................ 3484Liquid paraffin, light .............................................................. 3483Liquid preparations for cutaneous application ..................... 916Liquid preparations for cutaneous application, veterinary.. 941Liquid preparations for oral use ............................................. 916Liquid sorbitol (crystallising)................................................ 3867Liquid sorbitol (non-crystallising) ....................................... 3867Liquid sorbitol, partially dehydrated.................................... 3868Liquid sucrose ......................................................................... 3908Liquids, clarity and degree of opalescence of (2.2.1.) ............ 21Liquorice dry extract for flavouring purposes .................... 1508Liquorice root ......................................................................... 1509Lisinopril dihydrate .......................................................10.1-4443Lithium carbonate .................................................................. 3104Lithium citrate ........................................................................ 3105Live biotherapeutic products for human use ........................ 876Live biotherapeutic products, microbiological examinationof (tests for enumeration of microbial contaminants)(2.6.36.) .................................................................................... 250

Live biotherapeutic products, microbiological examination of(tests for specified micro-organisms) (2.6.38.) ................... 255

L-Methionine ([11C]methyl) injection .................................. 1220Lobeline hydrochloride.......................................................... 3105Lomustine ................................................................................ 3107Long pepper ............................................................................ 1510Loosestrife ............................................................................... 1511Loperamide hydrochloride.................................................... 3108Loperamide oxide monohydrate........................................... 3109Lopinavir.................................................................................. 3111Loratadine................................................................................ 3114Lorazepam ......................................................................10.4-5503Losartan potassium ................................................................ 3117Loss on drying (2.2.32.) ............................................................. 57Loss on drying of extracts (2.8.17.) ........................................ 311Lovage root .....................................................................10.3-4884Lovastatin .......................................................................10.4-5505Low-molecular-mass heparins.............................................. 2818Low-substituted carmellose sodium..................................... 2094Low-substituted hydroxypropylcellulose ............................. 2904Lozenges and pastilles ...................................................10.3-4827Lozenges, compressed ...................................................10.3-4827Lubricant, silicone oil (3.1.8.).................................................. 436Lufenuron for veterinary use ................................................ 3121Lutetium (177Lu) solution for radiolabelling........................ 1218Lycopus lucidus herb.............................................................. 1514Lymecycline............................................................................. 3123Lynestrenol .............................................................................. 3125Lyophilisates, oral ..................................................................... 939

Lysine acetate .......................................................................... 3126Lysine acetylsalicylate, DL-............................................10.3-5055Lysine hydrochloride.............................................................. 3127

MMacrogol 15 hydroxystearate ................................................ 3133Macrogol 20 glycerol monostearate...................................... 3134Macrogol 30 dipolyhydroxystearate ..................................... 3135Macrogol 40 sorbitol heptaoleate.......................................... 3135Macrogol 6 glycerol caprylocaprate...................................... 3133Macrogol cetostearyl ether .................................................... 3136Macrogol isotridecyl ether..................................................... 3137Macrogol lauryl ether............................................................. 3137Macrogol oleate....................................................................... 3139Macrogol oleyl ether............................................................... 3140Macrogol poly(vinyl alcohol) grafted copolymer ............... 3140Macrogol stearate.................................................................... 3142Macrogol stearyl ether ........................................................... 3142Macrogolglycerol cocoates..................................................... 3143Macrogolglycerol hydroxystearate ........................................ 3144Macrogolglycerol ricinoleate ................................................. 3144Macrogols ................................................................................ 3145Macrogols, high-molecular-mass ......................................... 3147Magaldrate ............................................................................... 3148Magnesium (2.4.6.)................................................................... 138Magnesium acetate tetrahydrate ........................................... 3149Magnesium aluminium silicate............................................. 1799Magnesium aluminometasilicate .................................10.4-5509Magnesium and alkaline-earth metals (2.4.7.)...................... 139Magnesium aspartate dihydrate............................................ 3151Magnesium carbonate, heavy................................................ 3153Magnesium carbonate, light .................................................. 3153Magnesium chloride 4.5-hydrate .......................................... 3154Magnesium chloride hexahydrate ...............................10.3-5061Magnesium citrate .................................................................. 3155Magnesium citrate dodecahydrate........................................ 3156Magnesium citrate nonahydrate ........................................... 3157Magnesium fluoratum for homoeopathic preparations.... 10.1-4370

Magnesium gluconate ............................................................ 3157Magnesium glycerophosphate............................................... 3158Magnesium hydroxide...................................................10.3-5061Magnesium lactate dihydrate ................................................ 3159Magnesium oxide, heavy ..............................................10.3-5062Magnesium oxide, light.................................................10.3-5062Magnesium peroxide.............................................................. 3161Magnesium phosphoricum for homoeopathicpreparations .......................................................................... 1722

Magnesium pidolate ............................................................... 3161Magnesium stearate................................................................ 3163Magnesium sulfate heptahydrate .................................10.3-5063Magnesium trisilicate ............................................................. 3165Magnolia biondii flower bud................................................. 1515Magnolia officinalis bark ....................................................... 1517Magnolia officinalis flower .................................................... 1519Maize oil, refined ...........................................................10.1-4447Maize starch ............................................................................ 3167Malathion................................................................................. 3167Maleic acid............................................................................... 3168Malic acid ................................................................................ 3169Mallow flower.......................................................................... 1520Mallow leaf .............................................................................. 1521Maltitol..................................................................................... 3170Maltitol, liquid ........................................................................ 3171Maltodextrin............................................................................ 3172Management of extraneous agents in immunologicalveterinary medicinal products (5.2.5.)......................10.2-4590

Mandarin epicarp and mesocarp.......................................... 1522Mandarin oil............................................................................ 1524Manganese gluconate ............................................................. 3173Manganese glycerophosphate, hydrated .............................. 3174Manganese sulfate monohydrate .......................................... 3174



Mannheimia vaccine (inactivated) for cattle....................... 1125Mannheimia vaccine (inactivated) for sheep ...................... 1126Mannitol .................................................................................. 3175Maprotiline hydrochloride .................................................... 3177Marbofloxacin for veterinary use.......................................... 3178Marek’s disease vaccine (live) .......................................10.2-4657Marshmallow leaf ................................................................... 1525Marshmallow root .................................................................. 1526Mass spectrometry (2.2.43.) ...................................................... 77Mass spectrometry, inductively coupled plasma- (2.2.58.).. 108Mass uniformity of delivered doses from multidose containers(2.9.27.) .................................................................................... 372

Mass uniformity of single-dose preparations (2.9.5.) .......... 335Mastic ....................................................................................... 1526Mate leaf................................................................................... 1527Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) .................................................................................... 437

Materials based on non-plasticised poly(vinyl chloride) forcontainers for solid dosage forms for oral administration(3.1.11.) .................................................................................... 439

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 445

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.3.2.) ...................................................................................... 465

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.3.3.)................................................................ 468

Materials for containers for human blood and bloodcomponents (3.3.1.)................................................................ 465

Materials used for the manufacture of containers (3.1.)...... 423Matricaria flower .................................................................... 1529Matricaria liquid extract ........................................................ 1530Matricaria oil........................................................................... 1531Meadowsweet .......................................................................... 1533Measles immunoglobulin, human ........................................ 2859Measles, mumps and rubella vaccine (live)......................... 1005Measles, mumps, rubella and varicella vaccine (live) ........ 1006Measles vaccine (live)............................................................. 1007Measurement and detection of radioactivity (2.2.66.) ......... 119Measurement of consistency by penetrometry (2.9.9.)........ 337Mebendazole ........................................................................... 3180Mebeverine hydrochloride .................................................... 3181Meclozine dihydrochloride.................................................... 3183Medicated chewing gums ........................................................ 907Medicated chewing gums, dissolution test for (2.9.25.)....... 365Medicated feeding stuffs for veterinary use, premixes for .. 927Medicated foams....................................................................... 911Medicated plasters .................................................................... 936Medicated tampons .................................................................. 940Medicated vaginal tampons..................................................... 941Medicinal air ........................................................................... 1768Medicinal air, synthetic.......................................................... 1770Medium-chain triglycerides .................................................. 4096Medronic acid for radiopharmaceutical preparations ....... 1219Medroxyprogesterone acetate................................................ 3184Mefenamic acid....................................................................... 3186Mefloquine hydrochloride..................................................... 3187Megestrol acetate .................................................................... 3189Meglumine............................................................................... 3191Meldonium dihydrate............................................................. 3192Melilot ...................................................................................... 1534Melissa leaf .............................................................................. 1536Melissa leaf dry extract .......................................................... 1537Meloxicam ............................................................................... 3193Melphalan ................................................................................ 3194Melting point - capillary method (2.2.14.) .............................. 32Melting point - instantaneous method (2.2.16.) ..................... 33Melting point - open capillary method (2.2.15.) .................... 33Menadione............................................................................... 3196

Meningococcal group A, C, W135 and Y conjugatevaccine ................................................................................... 1009

Meningococcal group C and haemophilus type b conjugatevaccine ..................................................................................... 979

Meningococcal group C conjugate vaccine ......................... 1010Meningococcal polysaccharide vaccine ............................... 1012Menthol, racemic .................................................................... 3197Mepivacaine hydrochloride ................................................... 3198Mepyramine maleate .............................................................. 3200Mercaptopurine monohydrate .....................................10.1-4447Mercuric chloride ..........................................................10.4-5510Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 377

Meropenem trihydrate ........................................................... 3203Mesalazine ............................................................................... 3204Mesna ....................................................................................... 3207Mesterolone ............................................................................. 3208Mestranol ................................................................................. 3209Metabisulfite, potassium ........................................................ 3607Metabisulfite, sodium....................................................10.3-5135Metacresol................................................................................ 3210Metal catalyst or metal reagent residues (5.20.).................... 815Metal catalyst or metal reagent residues, determination of(2.4.20.) .................................................................................... 144

Metamizole sodium monohydrate........................................ 3211Metered-dose preparations for inhalation, non-pressurised............................................................................... 930

Metered-dose preparations for inhalation, pressurised ....... 928Metformin hydrochloride.............................................10.1-4448Methacrylate copolymer, basic butylated ............................ 1925Methacrylic acid - ethyl acrylate copolymer (1:1).............. 3214Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ............................................................................. 3216

Methacrylic acid - methyl methacrylate copolymer (1:1).. 3217Methacrylic acid - methyl methacrylate copolymer (1:2).. 3218Methadone hydrochloride ..................................................... 3219Methane ................................................................................... 3220Methane intermix (2 per cent) in nitrogen ......................... 3221Methanesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.38.)................................................................. 183

Methanesulfonic acid, methanesulfonyl chloride in(2.5.39.) .................................................................................... 184

Methanesulfonic acid, methyl, ethyl and isopropylmethanesulfonate in (2.5.37.)................................................ 182

Methanesulfonyl chloride in methanesulfonic acid(2.5.39.) .................................................................................... 184

Methanol.................................................................................. 3222Methanol and 2-propanol, test for (2.9.11.) .......................... 342Methenamine .......................................................................... 3223Methionine .............................................................................. 3223Methionine ([11C]methyl) injection, L- ................................ 1220Methionine, DL- ...................................................................... 3225Methods in pharmacognosy (2.8.).......................................... 305Methods of preparation of homoeopathic stocks andpotentisation ......................................................................... 1682

Methods of preparation of sterile products (5.1.1.) ............. 619Methotrexate ........................................................................... 3225Methyl, ethyl and isopropyl benzenesulfonate in activesubstances (2.5.41.)................................................................. 186

Methyl, ethyl and isopropyl methanesulfonate in activesubstances (2.5.38.)................................................................. 183

Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid (2.5.37.) .............................................. 182

Methyl, ethyl and isopropyl toluenesulfonate in activesubstances (2.5.40.)................................................................. 185

Methyl methacrylate – methacrylic acid copolymer (1:1).. 3217Methyl methacrylate - methacrylic acid copolymer (1:2).. 3218Methyl nicotinate.................................................................... 3228Methyl parahydroxybenzoate................................................ 3229Methyl parahydroxybenzoate, sodium................................. 3830Methyl salicylate ..................................................................... 3230Methylcellulose ....................................................................... 3231Methyldopa.............................................................................. 3233



Methylene blue........................................................................ 3250Methylene chloride................................................................. 3235Methylergometrine maleate .................................................. 3236Methylhydroxyethylcellulose................................................. 3237Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 173Methylphenidate hydrochloride ........................................... 3238Methylphenobarbital .............................................................. 3239Methylprednisolone................................................................ 3240Methylprednisolone acetate................................................... 3243Methylprednisolone hydrogen succinate ............................. 3245Methylpyrrolidone, N- ........................................................... 3246Methylrosanilinium chloride ................................................ 3247Methyltestosterone ................................................................. 3249Methylthioninium chloride hydrate ..................................... 3250Metixene hydrochloride......................................................... 3251Metoclopramide...................................................................... 3252Metoclopramide hydrochloride monohydrate.................... 3253Metolazone .............................................................................. 3255Metoprolol succinate .............................................................. 3256Metoprolol tartrate ................................................................. 3258Metronidazole ......................................................................... 3261Metronidazole benzoate......................................................... 3262Mexiletine hydrochloride .............................................10.3-5064Mianserin hydrochloride ....................................................... 3264Miconazole .............................................................................. 3266Miconazole nitrate.................................................................. 3267Micro determination of water (2.5.32.).................................. 178Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ...................................10.3-4765

Microbiological assay of antibiotics (2.7.2.) .......................... 262Microbiological examination of cell-based preparations(2.6.27.) .........................................................................10.3-4773

Microbiological examination of herbal medicinal products fororal use and extracts used in their preparation (2.6.31.)... 239

Microbiological examination of live biotherapeuticproducts : tests for enumeration of microbial contaminants(2.6.36.) .................................................................................... 250

Microbiological examination of live biotherapeutic products :tests for specified micro-organisms (2.6.38.) ...................... 255

Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) .......................10.3-4765

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..........................10.3-4769

Microbiological quality, alternative methods for control of(5.1.6.) ...................................................................................... 628

Microbiological quality of herbal medicinal products for oraluse and extracts used in their preparation (5.1.8.)............. 638

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.) ...........................................................................10.3-4801

Microbiology, general texts on (5.1.) ..................................... 619Microcalorimetry and solution calorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 115

Microcrystalline cellulose .............................................10.4-5446Microcrystalline cellulose and carmellose sodium ............ 3269Microscopic examination of herbal drugs (2.8.23) .............. 317Microscopy, optical (2.9.37.) ................................................... 390Microscopy, scanning electron (2.9.52.) ................................ 414Midazolam............................................................................... 3270Milbemycin oxime for veterinary use .................................. 3272Milk thistle dry extract, refined and standardised ............. 1538Milk thistle fruit...................................................................... 1539Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.)...................................................................... 661

Minocycline hydrochloride dihydrate.........................10.3-5065Minoxidil ................................................................................. 3277Mint oil, partly dementholised ............................................. 1541Mirtazapine ............................................................................. 3278Misoprostol.............................................................................. 3279Mites for allergen products ................................................... 3281Mitomycin ............................................................................... 3282Mitoxantrone hydrochloride ................................................. 3283

Modafinil ................................................................................. 3285Modified-release capsules ........................................................ 907Modified-release granules........................................................ 912Modified-release tablets ........................................................... 939Mofetil mycophenolate .......................................................... 3312Molecular mass distribution in dextrans (2.2.39.).....10.3-4760Molgramostim concentrated solution.................................. 3286Molsidomine ........................................................................... 3288Molybdate dihydrate, sodium ............................................... 3831Mometasone furoate......................................................10.1-4450Mometasone furoate monohydrate ...................................... 3293Monoclonal antibodies for human use .................................. 878Monocyte-activation test (2.6.30.) .......................................... 233Monographs on herbal drug extracts (information chapter)(5.23.) ....................................................................................... 843

Monophosphoryl lipid A, 3-O-desacyl-4′- .......................... 2355Montelukast sodium............................................................... 3295Morantel hydrogen tartrate for veterinary use ................... 3298Morinda root ..................................................................10.4-5407Morphine hydrochloride ....................................................... 3299Morphine sulfate..................................................................... 3300Moss, Iceland........................................................................... 1480Mother tinctures for homoeopathic preparations .............. 1681Motherwort ............................................................................. 1542Moulds for allergen products ................................................ 3302Moutan bark............................................................................ 1543Mouthwashes..................................................................10.3-4826Moxidectin for veterinary use............................................... 3303Moxifloxacin hydrochloride .........................................10.3-5067Moxonidine ............................................................................. 3308Mucoadhesive preparations..........................................10.3-4828Mullein flower ......................................................................... 1545Multidose containers, uniformity of mass of delivered doses(2.9.27.) .................................................................................... 372

Multivariate statistical process control (5.28.) ...........10.4-5377Mumps, measles and rubella vaccine (live)......................... 1005Mumps, measles, rubella and varicella vaccine (live) ........ 1006Mumps vaccine (live) ............................................................. 1014Mupirocin .......................................................................10.3-5069Mupirocin calcium ........................................................10.3-5071Mycobacteria (2.6.2.)................................................................ 194Mycophenolate mofetil .......................................................... 3312Mycophenolate sodium.................................................10.3-5072Mycoplasma gallisepticum vaccine (inactivated) ............... 1129Mycoplasmas (2.6.7.)................................................................ 194myo-Inositol ...................................................................10.4-5495Myrrh ....................................................................................... 1546Myrrh tincture ........................................................................ 1547Myxomatosis vaccine (live) for rabbits .......................10.2-4659

NNabumetone ............................................................................ 3317N-Acetyltryptophan ............................................................... 1755N-Acetyltyrosine ..................................................................... 1757Nadolol..................................................................................... 3318Nadroparin calcium ............................................................... 3319Naftidrofuryl hydrogen oxalate ............................................ 3322Naloxone hydrochloride dihydrate....................................... 3325Naltrexone hydrochloride...................................................... 3327Names of herbal drugs used in traditional Chinese medicine(5.22.) ............................................................................10.4-5367

Nandrolone decanoate ..................................................10.1-4457Naphazoline hydrochloride ................................................... 3330Naphazoline nitrate ................................................................ 3331Naproxen ................................................................................. 3333Naproxen sodium ................................................................... 3335Narrow-leaved coneflower root ............................................ 1548Nasal drops .....................................................................10.3-4823Nasal powders ................................................................10.3-4825Nasal preparations .........................................................10.3-4823Nasal preparations, semi-solid.....................................10.3-4825Nasal sprays ....................................................................10.3-4824



Nasal sticks .....................................................................10.3-4825Nasal washes...................................................................10.3-4825Nateglinide .............................................................................. 3337Near-infrared spectroscopy (2.2.40.)........................................ 70Nebulisation, characterisation of preparations for(2.9.44.) .................................................................................... 404

Nebulisation, liquid preparations for ..................................... 928Neohesperidin-dihydrochalcone .......................................... 3339Neomycin sulfate ...........................................................10.3-5077Neonatal piglet colibacillosis vaccine (inactivated)............ 1132Neonatal ruminant colibacillosis vaccine (inactivated)..... 1133Neostigmine bromide....................................................10.4-5513Neostigmine metilsulfate ..............................................10.4-5514Neroli oil .................................................................................. 1550Netilmicin sulfate.................................................................... 3344Nettle leaf................................................................................. 1551Nettle root................................................................................ 1553Neurovirulence test of live viral vaccines (2.6.18.) ............... 218Nevirapine ............................................................................... 3346Nevirapine hemihydrate ...............................................10.3-5078Newcastle disease vaccine (inactivated)......................10.2-4660Newcastle disease vaccine (live)...................................10.2-4661Niaouli oil, cineole type ......................................................... 1554Nicardipine hydrochloride .................................................... 3348Nicergoline .............................................................................. 3349Nickel in hydrogenated vegetable oils (2.4.31.) .................... 163Nickel in polyols (2.4.15.) ........................................................ 143Niclosamide............................................................................. 3351Niclosamide monohydrate .................................................... 3352Nicorandil................................................................................ 3353Nicotinamide........................................................................... 3354Nicotine.................................................................................... 3355Nicotine ditartrate dihydrate................................................. 3356Nicotine resinate ..................................................................... 3357Nicotinic acid .......................................................................... 3359Nifedipine ................................................................................ 3360Niflumic acid........................................................................... 3362Nifuroxazide............................................................................ 3363Nikethamide............................................................................ 3364Nilotinib hydrochloride monohydrate................................. 3365Nilutamide............................................................................... 3367Nimesulide............................................................................... 3368Nimodipine ............................................................................. 3369Nitrazepam .............................................................................. 3371Nitrendipine ............................................................................ 3372Nitric acid ................................................................................ 3373Nitric oxide.............................................................................. 3373Nitrofural ................................................................................. 3374Nitrofurantoin......................................................................... 3375Nitrogen ................................................................................... 3376Nitrogen determination by sulfuric acid digestion (2.5.9.).. 170Nitrogen determination, primary aromatic amino (2.5.8.).. 169Nitrogen, low-oxygen............................................................. 3377Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) .................................................................................... 176

Nitroprusside, sodium ........................................................... 3832Nitrous oxide........................................................................... 3377Nitrous oxide in gases (2.5.35.)............................................... 182Nizatidine ................................................................................ 3379N-Methylpyrrolidone ............................................................. 3246NMR spectrometry (2.2.33.) ..................................................... 58NMR spectrometry, peptide identification by (2.2.64.)....... 118N,N-Dimethylaniline (2.4.26.) ................................................ 158Nomegestrol acetate ......................................................10.1-4459Nonoxinol 9............................................................................. 3381Non-sterile pharmaceutical preparations and substancesfor pharmaceutical use, microbiological quality of(5.1.4.) ...........................................................................10.3-4801

Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ....................10.3-4765

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.).........................10.3-4769

Noradrenaline hydrochloride................................................ 3382

Noradrenaline tartrate ........................................................... 3384Norepinephrine hydrochloride ............................................. 3382Norepinephrine tartrate......................................................... 3384Norethisterone ........................................................................ 3385Norethisterone acetate ........................................................... 3387Norfloxacin.....................................................................10.4-5515Norflurane ............................................................................... 3390Norgestimate ........................................................................... 3396Norgestrel ................................................................................ 3397Normal immunoglobulin for intramuscular administration,human .................................................................................... 2860

Normal immunoglobulin for intravenous administration,human .................................................................................... 2862

Normal immunoglobulin for subcutaneous administration,human .................................................................................... 2864

Nortriptyline hydrochloride.................................................. 3397Noscapine .......................................................................10.4-5517Noscapine hydrochloride hydrate......................................... 3400Notoginseng root .................................................................... 1555Nuclear magnetic resonance spectrometry (2.2.33.).............. 58Nuclear magnetic resonance spectrometry, peptideidentification by (2.2.64.)....................................................... 118

Nucleated cell count and viability (2.7.29.) ........................... 297Nucleic acid amplification techniques (2.6.21.) .................... 219Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 172Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) .................................................................................... 292

Nutmeg oil ............................................................................... 1556Nux-vomica for homoeopathic preparations ...................... 1723Nystatin.................................................................................... 3401

OO-Acetyl in polysaccharide vaccines (2.5.19.)....................... 173Oak bark .................................................................................. 1557Octoxinol 10 ............................................................................ 3405Octreotide................................................................................ 3405Octyl gallate............................................................................. 3407Octyldodecanol ....................................................................... 3407Odour (2.3.4.)............................................................................ 133Odour and taste of essential oils (2.8.8.)................................ 306Ofloxacin.........................................................................10.3-5083Oils, essential............................................................................. 864Oils, fatty, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 132

Oils, fatty, vegetable.................................................................. 901Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) .................................................................................... 161

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 163Ointments .................................................................................. 936Olanzapine............................................................................... 3410Olanzapine embonate monohydrate ...........................10.2-4677Olanzapine pamoate monohydrate .............................10.2-4677Oleic acid ................................................................................. 3411Oleoresins .................................................................................. 868Oleoyl macrogolglycerides .................................................... 3411Oleyl alcohol............................................................................ 3412Olive leaf .................................................................................. 1557Olive leaf dry extract .............................................................. 1559Olive oil, refined ..................................................................... 3413Olive oil, virgin ....................................................................... 3414Olmesartan medoxomil ......................................................... 3415Olsalazine sodium .................................................................. 3417Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) .................................................................................... 161

Omega-3 acids, fish oil rich in .............................................. 2639Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 163Omega-3-acid ethyl esters 60 ................................................ 3419Omega-3-acid ethyl esters 90 ................................................ 3421Omega-3-acid triglycerides ..........................................10.3-5084Omeprazole ............................................................................. 3425Omeprazole magnesium........................................................ 3427Omeprazole sodium ............................................................... 3428



Ondansetron hydrochloride dihydrate .......................10.4-5521Opalescence of liquids, clarity and degree of (2.2.1.)............. 21Ophthalmic inserts ................................................................... 910Opium dry extract, standardised.................................10.3-4885Opium, prepared .................................................................... 1561Opium, raw.............................................................................. 1562Opium tincture, standardised ............................................... 1564Optical microscopy (2.9.37.) ................................................... 390Optical rotation (2.2.7.) ............................................................. 26Oral drops.................................................................................. 918Oral lyophilisates ...................................................................... 939Oral powders ............................................................................. 926Oral solutions, emulsions and suspensions........................... 917Oral use, liquid preparations for ............................................ 916Oral use, veterinary semi-solid preparations for.................. 942Orbifloxacin for veterinary use ............................................. 3431Orciprenaline sulfate .............................................................. 3433Oregano ................................................................................... 1565Organ preservation, solutions for................................10.3-5135Oriental cashew for homoeopathic preparations ............... 1702Orientvine stem ...................................................................... 1567Orodispersible films ......................................................10.3-4828Orodispersible tablets .............................................................. 939Oromucosal capsules.....................................................10.3-4828Oromucosal drops .........................................................10.3-4827Oromucosal preparations .............................................10.3-4825Oromucosal preparations, semi-solid .........................10.3-4826Oromucosal solutions, emulsions and suspensions ..10.3-4826Oromucosal sprays ........................................................10.3-4825Oropharyngeal sprays ...................................................10.3-4827Orphenadrine citrate.............................................................. 3434Orphenadrine hydrochloride ................................................ 3436Oseltamivir phosphate ........................................................... 3437Osmolality (2.2.35.) .................................................................... 63Ouabain ................................................................................... 3439Oxacillin sodium monohydrate ............................................ 3440Oxaliplatin ............................................................................... 3442Oxazepam................................................................................ 3445Oxcarbazepine......................................................................... 3446Oxeladin hydrogen citrate ..................................................... 3448Oxfendazole for veterinary use ....................................10.1-4463Oxidising substances (2.5.30.)................................................. 177Oxitropium bromide .............................................................. 3450Oxolinic acid ........................................................................... 3451Oxybuprocaine hydrochloride .............................................. 3453Oxybutynin hydrochloride .................................................... 3454Oxycodone hydrochloride ..................................................... 3455Oxygen ..................................................................................... 3456Oxygen (15O) ........................................................................... 1222Oxygen (93 per cent).............................................................. 3457Oxygen in gases (2.5.27.) ......................................................... 176Oxygen-flask method (2.5.10.)................................................ 170Oxymetazoline hydrochloride......................................10.1-4464Oxytetracycline dihydrate.............................................10.2-4678Oxytetracycline hydrochloride.............................................. 3462Oxytocin .................................................................................. 3464Oxytocin concentrated solution............................................ 3465

PPaclitaxel .........................................................................10.3-5089Pale coneflower root............................................................... 1568Palmitic acid............................................................................ 3473Pamidronate disodium pentahydrate................................... 3474Pancreas powder ..................................................................... 3474Pancreatic necrosis vaccine (inactivated, oil-adjuvanted,injectable) for salmonids, infectious .................................. 1124

Pancuronium bromide ........................................................... 3477Panleucopenia vaccine (inactivated), feline ........................ 1109Panleucopenia vaccine (live), feline ............................10.2-4651Pansy, wild (flowering aerial parts)...................................... 1668Pantoprazole sodium sesquihydrate..................................... 3478Pantothenate, calcium...................................................10.4-5442

Papaverine hydrochloride...................................................... 3480Paper chromatography (2.2.26.) ............................................... 46Papillomavirus vaccine (rDNA), human .............................. 989Paraben, butyl ......................................................................... 2025Paraben, ethyl.......................................................................... 2583Paraben, methyl ...................................................................... 3229Paraben, propyl ....................................................................... 3660Paraben, sodium ethyl............................................................ 3816Paraben, sodium methyl ........................................................ 3830Paraben, sodium propyl......................................................... 3838Paracetamol ............................................................................. 3481Paraffin, hard........................................................................... 3483Paraffin, light liquid ............................................................... 3483Paraffin, liquid ........................................................................ 3484Paraffin, white soft.................................................................. 3485Paraffin, yellow soft ................................................................ 3486Parahydroxybenzoate, butyl .................................................. 2025Parahydroxybenzoate, ethyl .................................................. 2583Parahydroxybenzoate, methyl ............................................... 3229Parahydroxybenzoate, propyl................................................ 3660Parahydroxybenzoate, sodium ethyl .................................... 3816Parahydroxybenzoate, sodium methyl................................. 3830Parahydroxybenzoate, sodium propyl.................................. 3838Parainfluenza virus vaccine (live), bovine ..................10.2-4633Parainfluenza virus vaccine (live), canine ..................10.2-4640Paraldehyde ............................................................................. 3486Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ..............................................................................10.2-4660

Paramyxovirus 1 (Newcastle disease) vaccine (live),avian ..............................................................................10.2-4661

Paramyxovirus 3 vaccine (inactivated) for turkeys,avian ..............................................................................10.2-4631

Parenteral preparations............................................................ 923Parenteral preparations, depyrogenation of items used in theproduction of (5.1.12.) ................................................10.3-4806

Parenteral preparations, test for extractable volume of(2.9.17.) .................................................................................... 347

Parnaparin sodium................................................................. 3487Paroxetine hydrochloride .............................................10.4-5525Paroxetine hydrochloride hemihydrate ......................10.4-5527Particle size analysis by laser light diffraction (2.9.31.) ....... 373Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ................................................................. 347

Particle-size distribution estimation by analytical sieving(2.9.38.) .................................................................................... 392

Particulate contamination, recommendations on testing of :visible particles (5.17.2.) .............................................10.3-4809

Particulate contamination : sub-visible particles(2.9.19.) .........................................................................10.3-4785

Particulate contamination : visible particles (2.9.20.)........... 362Parvovirosis vaccine (inactivated), canine........................... 1085Parvovirosis vaccine (inactivated), porcine................10.2-4663Parvovirosis vaccine (live), canine...............................10.2-4641Passionflower herb.........................................................10.3-4887Passionflower herb dry extract.....................................10.3-4888Pastes .......................................................................................... 936Pasteurella vaccine (inactivated) for sheep.......................... 1138Pastilles and lozenges ....................................................10.3-4827Patches, cutaneous.................................................................... 935Patches, transdermal ................................................................ 925Patches, transdermal, dissolution test for (2.9.4.)................. 333Pea starch................................................................................. 3492Pefloxacin mesilate dihydrate................................................ 3493Pelargonium root .................................................................... 1571Pemetrexed disodium heptahydrate..................................... 3494Penbutolol sulfate ................................................................... 3497Penetrometry, measurement of consistency by (2.9.9.) ....... 337Penicillamine........................................................................... 3498Penicillin G (benzathine) tetrahydrate................................. 1951Penicillin G potassium........................................................... 1953Penicillin G (procaine) monohydrate..........................10.4-5436Penicillin G sodium................................................................ 1957Penicillin V.....................................................................10.2-4683



Penicillin V (benzathine) tetrahydrate................................. 3531Penicillin V potassium ..................................................10.2-4684Pentaerythrityl tetranitrate, diluted...................................... 3499Pentamidine diisetionate ....................................................... 3501Pentazocine.............................................................................. 3502Pentazocine hydrochloride.................................................... 3502Pentazocine lactate ................................................................. 3503Pentetate sodium calcium for radiopharmaceuticalpreparations .......................................................................... 1223

Pentobarbital ..................................................................10.3-5093Pentobarbital sodium....................................................10.3-5094Pentoxifylline .................................................................10.4-5529Pentoxyverine hydrogen citrate ............................................ 3509Peony root, red........................................................................ 1572Peony root, white .................................................................... 1573Pepper ...................................................................................... 1575Pepper, long............................................................................. 1510Peppermint leaf....................................................................... 1577Peppermint leaf dry extract................................................... 1578Peppermint oil ........................................................................ 1579Pepsin powder......................................................................... 3509Peptide identification by nuclear magnetic resonancespectrometry (2.2.64.) ............................................................ 118

Peptide mapping (2.2.55.).......................................................... 97Peptides, synthetic, acetic acid in (2.5.34.) ............................ 181Perborate, hydrated sodium .................................................. 3833Pergolide mesilate ................................................................... 3511Perindopril tert-butylamine .........................................10.1-4470Peritoneal dialysis, solutions for ........................................... 3515Permethrin (25:75) ................................................................. 3517Peroxide value (2.5.5.) .............................................................. 168Perphenazine........................................................................... 3519Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed) ......................................................10.3-4834

Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed, reduced antigen(s) content)......10.3-4835

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4839

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ....................10.3-4841

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed)........10.3-4843

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ......................................................10.3-4844

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4846

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ......................................................10.3-4849

Pertussis toxin (residual) (2.6.33.) .......................................... 241Pertussis vaccine (acellular), assay of (2.7.16.)...................... 286Pertussis vaccine (acellular, component, adsorbed)........... 1015Pertussis vaccine (acellular, co-purified, adsorbed) ........... 1016Pertussis vaccine (whole cell, adsorbed).............................. 1018Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 274Pertussis (whole cell), diphtheria and tetanus vaccine(adsorbed) ....................................................................10.3-4836

Pertussis (whole cell), diphtheria, tetanus and poliomyelitis(inactivated) vaccine (adsorbed) ...............................10.3-4851

Pertussis (whole cell), diphtheria, tetanus, poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ....................................................................10.3-4853

Peru balsam ............................................................................. 1580Pessaries ..................................................................................... 940Pessaries and suppositories, disintegration of (2.9.2.) ......... 325Pesticide residues (2.8.13.)....................................................... 308Pethidine hydrochloride ........................................................ 3520Petroleum rectificatum for homoeopathic preparations ... 1725pH of solutions, approximate (2.2.4.)....................................... 25pH, potentiometric determination of (2.2.3.) ......................... 24Pharmaceutical preparations................................................... 880

Pharmaceutical technical procedures (2.9.) .......................... 323Pharmacognosy, methods in (2.8.)......................................... 305Pharmacopoeial harmonisation (5.8.) ................................... 755Phenazone................................................................................ 3522Pheniramine maleate.............................................................. 3523Phenobarbital .......................................................................... 3524Phenobarbital sodium............................................................ 3525Phenol ...................................................................................... 3527Phenol in immunosera and vaccines (2.5.15.) ...................... 172Phenolphthalein...................................................................... 3527Phenolsulfonphthalein ........................................................... 3528Phenothiazines, identification by thin-layer chromatography(2.3.3.) ...................................................................................... 133

Phenoxyethanol ...................................................................... 3529Phenoxymethylpenicillin ..............................................10.2-4683Phenoxymethylpenicillin (benzathine) tetrahydrate.......... 3531Phenoxymethylpenicillin potassium ...........................10.2-4684Phentolamine mesilate ........................................................... 3535Phenylalanine .......................................................................... 3536Phenylbutazone....................................................................... 3538Phenylbutyrate, sodium ......................................................... 3833Phenylephrine ................................................................10.3-5096Phenylephrine hydrochloride.......................................10.3-5097Phenylmercuric acetate .......................................................... 3542Phenylmercuric borate........................................................... 3542Phenylmercuric nitrate .......................................................... 3543Phenylpropanolamine hydrochloride .................................. 3543Phenytoin................................................................................. 3545Phenytoin sodium................................................................... 3546Phloroglucinol......................................................................... 3548Phloroglucinol dihydrate ....................................................... 3549Pholcodine monohydrate ...................................................... 3551Phosphates (2.4.11.).................................................................. 142Phospholipids for injection, egg ........................................... 2494Phospholipids for injection, soya.......................................... 3870Phosphoric acid, concentrated.............................................. 3553Phosphoric acid, dilute .......................................................... 3553Phosphorus in polysaccharide vaccines (2.5.18.) ................. 172Phthalylsulfathiazole .............................................................. 3553Physical and physico-chemical methods (2.2.) ....................... 21Physostigmine salicylate ........................................................ 3554Phytomenadione, racemic ..................................................... 3555Phytonadione, racemic........................................................... 3555Phytosterol............................................................................... 3557Picosulfate, sodium ................................................................ 3835Picotamide monohydrate....................................................... 3558Piglet colibacillosis vaccine (inactivated), neonatal ........... 1132Pillules for homoeopathic preparations......................10.3-4894Pillules, homoeopathic, coated ............................................. 1697Pillules, homoeopathic, impregnated................................... 1697Pilocarpine hydrochloride ..................................................... 3559Pilocarpine nitrate .................................................................. 3560Pimobendan for veterinary use....................................10.3-5099Pimozide .................................................................................. 3562Pindolol.................................................................................... 3563Pine (dwarf) oil....................................................................... 1419Pine sylvestris oil .................................................................... 1581Pioglitazone hydrochloride ................................................... 3565Pipemidic acid trihydrate ...................................................... 3566Piperacillin monohydrate .............................................10.4-5531Piperacillin sodium .......................................................10.4-5534Piperazine adipate .................................................................. 3570Piperazine citrate .................................................................... 3571Piperazine hydrate .................................................................. 3572Piracetam........................................................................10.4-5538Pirenzepine dihydrochloride monohydrate ........................ 3574Piretanide................................................................................. 3575Pirfenidone .............................................................................. 3576Piroxicam................................................................................. 3577Pivampicillin ........................................................................... 3579Pivmecillinam hydrochloride................................................ 3581Plasma for fractionation, human.......................................... 2865



Plasma (pooled and treated for virus inactivation),human .................................................................................... 2867

Plasmid vectors for human use, bacterial cells used for themanufacture of........................................................................ 781

Plasmin inhibitor, assay of human (2.7.25.).......................... 295Plasters, medicated ................................................................... 935Plastic additives (3.1.13.) ......................................................... 441Plastic containers and closures for pharmaceutical use(3.2.2.) ...................................................................................... 459

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ................................................................................... 460

Plastic containers for human blood and blood components,sterile (3.3.4.)................................................................10.3-4791

Plastic syringes, single-use, sterile (3.3.8.)..................10.3-4792Platycodon root....................................................................... 1582Pneumococcal polysaccharide conjugate vaccine(adsorbed) ............................................................................. 1019

Pneumococcal polysaccharide vaccine ................................ 1021Pneumonia vaccine (inactivated), porcine enzootic .......... 1141Podophyllotoxin...................................................................... 3582Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content)....................10.3-4838

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ..............10.3-4843

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content).........................................................................10.3-4844

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(whole cell) vaccine (adsorbed) .................................10.3-4851

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed) ......................................................10.3-4849

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) .........................10.3-4846

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(whole cell) and haemophilus type b conjugate vaccine(adsorbed) ....................................................................10.3-4853

Poliomyelitis vaccine (inactivated) ....................................... 1023Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .................................................................................... 289

Poliomyelitis vaccine (oral) ................................................... 1026Pollens for allergen products................................................. 3583Poloxamers .............................................................................. 3584Polyacrylate dispersion 30 per cent ...................................... 3586Polyamide suture, sterile, in distributor for veterinaryuse........................................................................................... 1282

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.)................... 434

Polyethylene oxides, high-molecular-mass ......................... 3147Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .................................................... 448

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use........................................................................ 1283

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.)...... 427

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.)...... 426

Polyethyleneglycols................................................................. 3145Polyethyleneglycols, high-molecular-mass.......................... 3147Polygonum cuspidatum rhizome and root.......................... 1583Polygonum orientale fruit ..................................................... 1585Polymorphism (5.9.)................................................................. 759Polymyxin B sulfate .......................................................10.3-5100Polyolefins (3.1.3.) .................................................................... 423Polyoxyl castor oil................................................................... 3144Polyoxyl hydrogenated castor oil .......................................... 3144Polyoxypropylene stearyl ether ............................................. 3588Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)............ 431

Polysaccharide vaccines for human use, conjugated, carrierproteins for the production of (5.2.11.) ............................... 674

Polysaccharide vaccines, hexosamines in (2.5.20.) ............... 173

Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 173Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 172Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 173Polysaccharide vaccines, phosphorus in (2.5.18.)................. 172Polysaccharide vaccines, protein in (2.5.16.)......................... 172Polysaccharide vaccines, ribose in (2.5.31.) .......................... 177Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 174Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 174Polysorbate 20 ......................................................................... 3589Polysorbate 40 ......................................................................... 3590Polysorbate 60 ......................................................................... 3591Polysorbate 80 ......................................................................... 3591Polystyrene sulfonate, sodium .............................................. 3836Poly(vinyl acetate) .................................................................. 3593Poly(vinyl acetate) dispersion 30 per cent ........................... 3594Poly(vinyl alcohol).................................................................. 3595Poly(vinyl alcohol) macrogol grafted copolymer ............... 3140Poly(vinyl chloride) (non-plasticised) for containers for soliddosage forms for oral administration, materials based on(3.1.11.) .................................................................................... 439

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).. 437

Poly(vinyl chloride), plasticised, empty sterile containers of,for human blood and blood components (3.3.5.) .............. 473

Poly(vinyl chloride), plasticised, materials based on, forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 445

Poly(vinyl chloride), plasticised, materials based on, forcontainers for human blood and blood components(3.3.2.) ...................................................................................... 465

Poly(vinyl chloride), plasticised, materials based on, fortubing used in sets for the transfusion of blood and bloodcomponents (3.3.3.)................................................................ 468

Poly(vinyl chloride), plasticised, sterile containers of, forhuman blood containing anticoagulant solution (3.3.6.) .. 474

Poppy petals, red..................................................................... 1595Porcine actinobacillosis vaccine (inactivated) .................... 1139Porcine enzootic pneumonia vaccine (inactivated) ........... 1141Porcine influenza vaccine (inactivated) ............................... 1142Porcine insulin ........................................................................ 2957Porcine parvovirosis vaccine (inactivated).................10.2-4663Porcine progressive atrophic rhinitis vaccine(inactivated) .......................................................................... 1144

Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) ............................................................. 377

Poria ......................................................................................... 1587Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 377

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.).............................................................. 377

Porosity of sintered-glass filters (2.1.2.) ................................... 15Porous solids including powders, wettability of (2.9.45.) .... 406Potassium (2.4.12.) ................................................................... 142Potassium acetate.................................................................... 3596Potassium bromide................................................................. 3597Potassium carbonate............................................................... 3598Potassium chloride ........................................................10.4-5539Potassium citrate..................................................................... 3599Potassium clavulanate ...................................................10.3-5102Potassium clavulanate, diluted.....................................10.3-5104Potassium dichromate for homoeopathic preparations..... 1721Potassium dihydrogen phosphate......................................... 3603Potassium disulfite.................................................................. 3607Potassium hydrogen aspartate hemihydrate ....................... 3604Potassium hydrogen carbonate ............................................. 3605Potassium hydrogen tartrate ........................................10.4-5539Potassium hydroxide .............................................................. 3606Potassium iodide..................................................................... 3606Potassium metabisulfite ......................................................... 3607Potassium nitrate .................................................................... 3607Potassium perchlorate............................................................ 3608Potassium permanganate....................................................... 3609Potassium sodium tartrate tetrahydrate .............................. 3609



Potassium sorbate ................................................................... 3610Potassium sulfate .................................................................... 3610Potato starch............................................................................ 3611Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 64

Potentiometric determination of pH (2.2.3.) .......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathic stocksand.......................................................................................... 1682

Poultices ..................................................................................... 936Pour-on preparations ............................................................... 942Povidone .................................................................................. 3612Povidone, iodinated................................................................ 3615Powder fineness (2.9.35.) ......................................................... 387Powder flow (2.9.36.)................................................................ 387Powder flow properties by shear cell methods (2.9.49.) ...... 411Powdered cellulose ........................................................10.4-5450Powders and granules for oral solutions and suspensions .. 917Powders and granules for syrups ............................................ 918Powders and tablets for rectal solutions and suspensions... 934Powders, bulk density and tapped density of (2.9.34.)......... 384Powders, ear .............................................................................. 909Powders, effervescent ............................................................... 927Powders for cutaneous application......................................... 925Powders for eye drops and powders for eye lotions ............. 910Powders for injections or infusions........................................ 924Powders for oral drops............................................................. 918Powders, inhalation .................................................................. 931Powders, nasal ................................................................10.3-4825Powders, oral ............................................................................. 926Powders, wettability of porous solids including (2.9.45.) .... 406Pramipexole dihydrochloride monohydrate ....................... 3615Prasugrel hydrochloride......................................................... 3617Pravastatin sodium................................................................. 3618Prazepam ................................................................................. 3620Praziquantel............................................................................. 3621Prazosin hydrochloride.................................................10.1-4473Precursors for radiopharmaceutical preparations,chemical ................................................................................... 863

Prednicarbate .................................................................10.4-5540Prednisolone...................................................................10.4-5542Prednisolone acetate......................................................10.3-5105Prednisolone pivalate ............................................................. 3629Prednisolone sodium phosphate........................................... 3630Prednisone......................................................................10.3-5107Pregabalin ................................................................................ 3633Pregelatinised hydroxypropyl starch .................................... 3890Pregelatinised starch............................................................... 3891Prekallikrein activator (2.6.15.)............................................... 213Premixes for medicated feeding stuffs for veterinary use ... 927Preparations for inhalation ..................................................... 927Preparations for inhalation: aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 347

Preparations for irrigation....................................................... 932Preparations for nebulisation : characterisation (2.9.44.) .... 404Preservative and anticoagulant solutions for humanblood ...................................................................................... 1856

Pressurised pharmaceutical preparations .............................. 933Prilocaine................................................................................. 3635Prilocaine hydrochloride ....................................................... 3636Primaquine diphosphate...............................................10.1-4476Primary aromatic amino-nitrogen, determination of(2.5.8.) ...................................................................................... 169

Primary standards for volumetric solutions (4.2.1.) ..10.4-5360Primidone .......................................................................10.3-5109Primula root ............................................................................ 1588Principles for the detection of extraneous viruses inimmunological veterinary medicinal products using culturemethods (2.6.37.) .........................................................10.3-4778

Probenecid............................................................................... 3640Procainamide hydrochloride................................................. 3641Procaine benzylpenicillin monohydrate .....................10.4-5436Procaine hydrochloride.......................................................... 3642

Procaine penicillin G monohydrate ............................10.4-5436Process analytical technology (5.25.) ..........................10.4-5371Process control, statistical, multivariate (5.28.) .........10.4-5377Prochlorperazine maleate ...................................................... 3642Products of fermentation..............................................10.4-5387Products of recombinant DNA technology........................... 888Products with risk of transmitting agents of animal spongiformencephalopathies .................................................................... 884

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) .................................................................... 296

Progesterone............................................................................ 3644Progressive atrophic rhinitis vaccine (inactivated),porcine ................................................................................... 1144

Proguanil hydrochloride........................................................ 3646Proline...................................................................................... 3647Promazine hydrochloride .............................................10.4-5544Promethazine hydrochloride........................................10.4-5544Propacetamol hydrochloride................................................. 3651Propafenone hydrochloride................................................... 3652Propanol................................................................................... 3654Propanol and methanol, 2-, test for (2.9.11.) ........................ 342Propantheline bromide .......................................................... 3655Propofol ................................................................................... 3656Propranolol hydrochloride .................................................... 3658Propyl gallate........................................................................... 3659Propyl parahydroxybenzoate................................................. 3660Propyl parahydroxybenzoate, sodium ................................. 3838Propylene glycol...................................................................... 3661Propylene glycol dicaprylocaprate........................................ 3662Propylene glycol dilaurate ..................................................... 3662Propylene glycol monolaurate............................................... 3663Propylene glycol monopalmitostearate................................ 3664Propylene glycol monostearate ............................................. 3664Propylthiouracil ...................................................................... 3665Propyphenazone ............................................................10.4-5546Protamine sulfate.................................................................... 3667Protein assays, host-cell (2.6.34.) ............................................ 244Protein C, human, assay of (2.7.30.)....................................... 299Protein in polysaccharide vaccines (2.5.16.) ......................... 172Protein S, human, assay of (2.7.31.) ....................................... 300Protein, total (2.5.33.) .............................................................. 178Prothrombin complex, human.............................................. 2870Protirelin.................................................................................. 3669Proxyphylline .......................................................................... 3670Pseudoephedrine hydrochloride........................................... 3671PSMA-11 (gallium (68Ga)) injection ...........................10.4-5397Psyllium seed........................................................................... 1588Pullulan.................................................................................... 3672Pulsed electrochemical detection and direct amperometricdetection (2.2.63.) ................................................................... 117

Purified water .......................................................................... 4207Purple coneflower herb.......................................................... 1589Purple coneflower root .......................................................... 1591Pycnometric density of solids, gas (2.9.23.) .......................... 364Pygeum africanum bark ........................................................ 1593Pyrantel embonate.........................................................10.1-4478Pyrazinamide .......................................................................... 3674Pyridostigmine bromide ........................................................ 3675Pyridoxine hydrochloride...................................................... 3676Pyrimethamine ..............................................................10.1-4479Pyrogens (2.6.8.) ....................................................................... 199Pyrophosphate (sodium) decahydrate for radiopharmaceuticalpreparations .......................................................................... 1241

Pyrrolidone.............................................................................. 3678

QQuality control of vaccines, substitution of in vivo method(s)by in vitro method(s) for the (5.2.14.) ................................. 679

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.) ...........................................................................10.3-4801



Quantification and characterisation of residual host-cell DNA(2.6.35.) .................................................................................... 248

Quetiapine fumarate .............................................................. 3683Quillaia bark............................................................................ 1593Quinapril hydrochloride........................................................ 3685Quinidine sulfate .................................................................... 3687Quinine hydrochloride .......................................................... 3689Quinine sulfate........................................................................ 3690

RRabbit haemorrhagic disease vaccine (inactivated) ..10.2-4665Rabeprazole sodium............................................................... 3695Rabeprazole sodium hydrate........................................10.1-4483Rabies immunoglobulin, human .......................................... 2871Rabies vaccine for human use prepared in cell cultures.... 1030Rabies vaccine (inactivated) for veterinary use .........10.4-5391Rabies vaccine (live, oral) for foxes and raccoondogs ...............................................................................10.2-4666

Racecadotril............................................................................. 3698Racementhol............................................................................ 3197Racemic camphor ................................................................... 2069Racemic ephedrine hydrochloride ....................................... 2513Racemic menthol .................................................................... 3197Racephedrine hydrochloride................................................. 2513Raclopride ([11C]methoxy) injection.................................... 1224Radioactivity, detection and measurement of (2.2.66.) ....... 119Radiolabelling, fluoride (18F) solution for ........................... 1194Radiolabelling, gallium (68Ga) chloride (accelerator-produced)solution for ...................................................................10.3-4864

Radiolabelling, gallium (68Ga) chloride solution for .......... 1206Radiolabelling, lutetium (177Lu) solution for....................... 1218Radiolabelling, sodium iodide (123I) solution for................ 1228Radiolabelling, sodium iodide (131I) solution for................ 1232Radiolabelling, yttrium (90Y) chloride solution for ............ 1265Radionuclides, table of physical characteristics (5.7.).......... 745Radiopharmaceutical preparations ........................................ 884Radiopharmaceutical preparations, betiatide for ......10.3-4863Radiopharmaceutical preparations, chemical precursorsfor ............................................................................................. 863

Radiopharmaceutical preparations, copper tetramibitetrafluoroborate for............................................................. 1187

Radiopharmaceutical preparations, iobenguane sulfatefor ........................................................................................... 1216

Radiopharmaceutical preparations, medronic acid for ..... 1219Radiopharmaceutical preparations, pentetate sodium calciumfor ........................................................................................... 1223

Radiopharmaceutical preparations, sodium iodohippuratedihydrate for.......................................................................... 1234

Radiopharmaceutical preparations, sodium pyrophosphatedecahydrate for ..................................................................... 1241

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for .............................................................................. 1261

Radiopharmaceuticals, extemporaneous preparation of(5.19.) ....................................................................................... 807

Raloxifene hydrochloride ...................................................... 3699Raltegravir chewable tablets .........................................10.3-5114Raltegravir potassium ...................................................10.3-5113Raltegravir tablets ..........................................................10.3-5116Raman spectroscopy (2.2.48.) ................................................... 92Ramipril ................................................................................... 3705Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) ................................................... 295

Ranitidine hydrochloride..............................................10.2-4689Rapeseed oil, refined .............................................................. 3709Raspberry leaf ................................................................10.1-4359Raw materials of biological origin for the production ofcell-based and gene therapymedicinal products (5.2.12.).. 675

Reagents (4.) ...................................................................10.4-5231Reagents (4.1.1.).............................................................10.4-5231Reagents, standard solutions, buffer solutions (4.1.) ..10.4-5231Recombinant DNA technology, products of......................... 888

Recombinant factor C, test for bacterial endotoxins using(2.6.32.) .........................................................................10.3-4776

Recombinant vectors ............................................................... 779Recommendations on dissolution testing (5.17.1.) .............. 801Recommendations on methods for dosage forms testing(5.17.) ....................................................................................... 801

Recommendations on testing of particulate contamination :visible particles (5.17.2.) .............................................10.3-4809

Rectal capsules .......................................................................... 934Rectal foams .............................................................................. 935Rectal preparations................................................................... 933Rectal preparations, semi-solid............................................... 935Rectal solutions and suspensions, powders and tablets for.. 933Rectal solutions, emulsions and suspensions........................ 934Rectal tampons.......................................................................... 935Red peony root........................................................................ 1572Red poppy petals..................................................................... 1595Reference standards (5.12.) ..................................................... 773Refractive index (2.2.6.) ............................................................. 26Regorafenib monohydrate ..................................................... 3710Regorafenib tablets ........................................................10.4-5551Rehmannia root .............................................................10.1-4360Relative density (2.2.5.) .............................................................. 25Remifentanil hydrochloride .................................................. 3711Repaglinide.............................................................................. 3714Reserpine ................................................................................. 3715Residual pertussis toxin (2.6.33.)............................................ 241Residual solvents (5.4.) ............................................................ 717Residual solvents, identification and control of(2.4.24.) .........................................................................10.1-4323

Residue on evaporation of essential oils (2.8.9.)................... 306Residues, pesticide (2.8.13.)..................................................... 308Resistance to crushing of tablets (2.9.8.) ............................... 337Resorcinol ................................................................................ 3716Respiratory syncytial virus vaccine (live), bovine .....10.2-4634Restharrow root ...................................................................... 1596Rhatany root............................................................................ 1597Rhatany tincture ..................................................................... 1598Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1120Rhinotracheitis vaccine (inactivated), viral, feline ............. 1113Rhinotracheitis vaccine (live), bovine, infectious......10.2-4654Rhinotracheitis vaccine (live), infectious, turkey ......10.2-4668Rhinotracheitis vaccine (live), viral, feline .................10.2-4652Rhubarb ................................................................................... 1598Ribavirin .................................................................................. 3717Riboflavin................................................................................. 3718Riboflavin sodium phosphate ............................................... 3720Ribose in polysaccharide vaccines (2.5.31.) .......................... 177Ribwort plantain ..................................................................... 1599Rice starch ............................................................................... 3721Rifabutin .................................................................................. 3722Rifampicin ............................................................................... 3724Rifamycin sodium..........................................................10.3-5117Rifaximin ................................................................................. 3726Rilmenidine dihydrogen phosphate ..................................... 3728Riociguat .........................................................................10.4-5553Riociguat tablets.............................................................10.4-5554Risedronate sodium 2.5-hydrate........................................... 3729Risperidone ............................................................................. 3730Ritonavir .................................................................................. 3732Rivaroxaban....................................................................10.3-5119Rivaroxaban tablets .......................................................10.4-5556Rivastigmine...................................................................10.3-5121Rivastigmine hydrogen tartrate ............................................ 3737Rizatriptan benzoate .............................................................. 3739Rocuronium bromide............................................................. 3740Rolling ball (automatic) and falling ball viscometer methods(2.2.49.) .........................................................................10.3-4761

Roman chamomile flower...................................................... 1384Ropinirole hydrochloride ...................................................... 3742Ropivacaine hydrochloride monohydrate ........................... 3744Roselle .............................................................................10.4-5409Rosemary leaf.......................................................................... 1601



Rosemary oil ........................................................................... 1603Rosuvastatin calcium.....................................................10.1-4484Rosuvastatin tablets .......................................................10.3-5122Rotating viscometer method - viscosity (2.2.10.) ................... 28Rotation, optical (2.2.7.) ............................................................ 26Rotavirus diarrhoea vaccine (inactivated), calf .........10.2-4636Rotavirus vaccine (live, oral)................................................. 1033Rotigotine ................................................................................ 3748Round amomum fruit ............................................................ 1604Roxithromycin ........................................................................ 3750RRR-α-Tocopherol.................................................................. 4058RRR-α-Tocopheryl acetate..................................................... 4060RRR-α-Tocopheryl hydrogen succinate ............................... 4064Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ...................................................................................... 460

Rubella immunoglobulin, human ........................................ 2872Rubella, measles and mumps vaccine (live) ........................ 1005Rubella, measles, mumps and varicella vaccine (live)........ 1006Rubella vaccine (live) ............................................................. 1035Ruminant colibacillosis vaccine (inactivated), neonatal.... 1133Rupatadine fumarate .............................................................. 3752Rutoside trihydrate ................................................................. 3753

SSaccharin.................................................................................. 3759Saccharin sodium ................................................................... 3760Safety, viral (5.1.7.) ................................................................... 637Safflower flower ...................................................................... 1606Safflower oil, refined............................................................... 3761Saffron for homoeopathic preparations............................... 1710Sage leaf (Salvia officinalis) ................................................... 1607Sage leaf, three-lobed ............................................................. 1608Sage oil, Spanish...................................................................... 1629Sage tincture ............................................................................ 1609Salbutamol ............................................................................... 3761Salbutamol sulfate................................................................... 3764Salicylic acid ............................................................................ 3766Salmeterol xinafoate ............................................................... 3767Salmon oil, farmed ........................................................10.3-5127Salmonella Enteritidis vaccine (inactivated) for chickens.. 1151Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1152Salmonella Typhimurium vaccine (inactivated) forchickens ................................................................................. 1155

Salmonella Typhimurium vaccine (live, oral) forchickens ................................................................................. 1156

Salmonids, infectious pancreatic necrosis vaccine (inactivatedoil-adjuvanted, injectable) for ............................................. 1124

Salvia miltiorrhiza root and rhizome................................... 1610Sanguisorba root............................................................10.4-5410Saponification value (2.5.6.) .................................................... 169Saquinavir mesilate................................................................. 3771Saw palmetto extract .............................................................. 1612Saw palmetto fruit .................................................................. 1615Scanning electron microscopy (2.9.52.)................................. 414Schisandra fruit....................................................................... 1617Scopolamine ............................................................................ 2909Scopolamine butylbromide ................................................... 2910Scopolamine hydrobromide .................................................. 2911Selamectin for veterinary use................................................ 3773Selegiline hydrochloride ........................................................ 3775Selenium disulfide .................................................................. 3776Selenium for homoeopathic preparations ........................... 1725Selfheal fruit-spike, common ................................................ 1401Semi-micro determination of water (2.5.12.)........................ 171Semi-solid ear preparations..................................................... 908Semi-solid eye preparations .................................................... 910Semi-solid intrauterine preparations ..................................... 914Semi-solid nasal preparations ......................................10.3-4825Semi-solid oromucosal preparations...........................10.3-4826Semi-solid preparations for cutaneous application.............. 935Semi-solid preparations for oral use, veterinary .................. 942

Semi-solid rectal preparations ................................................ 935Semi-solid vaginal preparations ............................................. 941Senega root .............................................................................. 1618Senna leaf dry extract, standardised .................................... 1621Senna leaflet....................................................................10.1-4361Senna pods .....................................................................10.1-4363Separation techniques, chromatographic (2.2.46.) ................. 80Serine........................................................................................ 3777Serratula coronata herb.......................................................... 1624Sertaconazole nitrate .............................................................. 3778Sertraline hydrochloride........................................................ 3779Sesame oil, refined.................................................................. 3781Sets for the transfusion of blood and blood components(3.3.7.) ...................................................................................... 475

Sevoflurane .............................................................................. 3783Shampoos .................................................................................. 916Shear cell methods, powder flow properties by (2.9.49.)..... 411Shellac ..................................................................................... 3785Shingles (herpes zoster) vaccine (live) ................................. 1036SI (International System) units (1.) ............................................ 3Sialic acid in polysaccharide vaccines (2.5.23.)..................... 174Siam benzoin........................................................................... 1341Siam benzoin tincture ............................................................ 1342Sieve test (2.9.12.) ..................................................................... 343Sieves (2.1.4.)............................................................................... 16Sieving, analytical, particle-size distribution estimation by(2.9.38.) .................................................................................... 392

Sildenafil citrate ...................................................................... 3786Silica, colloidal anhydrous..................................................... 3787Silica, colloidal hydrated........................................................ 3788Silica, dental type.................................................................... 3788Silica, hydrophobic colloidal ................................................. 3789Silicate, aluminium magnesium............................................ 1799Silicate, aluminium sodium................................................... 1803Silicone elastomer for closures and tubing (3.1.9.)............... 436Silicone oil used as a lubricant (3.1.8.)................................... 436Silk suture, sterile, braided, in distributor for veterinaryuse........................................................................................... 1283

Silver, colloidal...............................................................10.3-5129Silver nitrate ............................................................................ 3790Simeticone ............................................................................... 3791Simvastatin .............................................................................. 3792Single-dose preparations, uniformity of content (2.9.6.)..... 336Single-dose preparations, uniformity of mass (2.9.5.) ......... 335Sintered-glass filters (2.1.2.) ...................................................... 15Sitagliptin phosphate monohydrate ..................................... 3795Sitagliptin tablets ...........................................................10.3-5130Size-exclusion chromatography (2.2.30.)................................. 51(S)-Lactic acid ......................................................................... 3051Smallpox vaccine (live) .......................................................... 1037Sodium acetate ([1-11C]) injection........................................ 1225Sodium acetate trihydrate.............................................10.3-5131Sodium alendronate trihydrate ............................................. 3798Sodium alginate ...................................................................... 3799Sodium aluminium silicate.................................................... 1803Sodium amidotrizoate............................................................ 3800Sodium aminosalicylate dihydrate ..............................10.4-5561Sodium ascorbate ................................................................... 3802Sodium aurothiomalate ......................................................... 3804Sodium benzoate .................................................................... 3805Sodium bromide ..................................................................... 3806Sodium calcium edetate......................................................... 3807Sodium calcium pentetate for radiopharmaceuticalpreparations .......................................................................... 1223

Sodium caprylate .................................................................... 3808Sodium carbonate..........................................................10.3-5132Sodium carbonate decahydrate....................................10.3-5132Sodium carbonate monohydrate .................................10.3-5133Sodium carboxymethylcellulose ........................................... 2093Sodium carboxymethylcellulose, cross-linked.................... 2318Sodium carboxymethylcellulose, low-substituted .............. 2094Sodium cetostearyl sulfate..................................................... 3810Sodium chloride.............................................................10.4-5562



Sodium chromate (51Cr) sterile solution.............................. 1226Sodium citrate ......................................................................... 3813Sodium cromoglicate ....................................................10.4-5563Sodium cyclamate................................................................... 3814Sodium dihydrogen phosphate dihydrate ..................10.3-5133Sodium disulfite .............................................................10.3-5135Sodium ethyl parahydroxybenzoate..................................... 3816Sodium fluoride ...................................................................... 3818Sodium fluoride (18F) injection............................................. 1227Sodium fusidate ...................................................................... 3818Sodium glycerophosphate, hydrated .................................... 3821Sodium hyaluronate ............................................................... 3821Sodium hydrogen carbonate ........................................10.3-5133Sodium hydroxide .................................................................. 3824Sodium iodide......................................................................... 3825Sodium iodide (123I) injection ............................................... 1228Sodium iodide (123I) solution for radiolabelling ................. 1228Sodium iodide (131I) capsules for diagnostic use ................ 1229Sodium iodide (131I) capsules for therapeutic use............... 1230Sodium iodide (131I) solution .......................................10.4-5398Sodium iodide (131I) solution for radiolabelling ................. 1232Sodium iodohippurate (123I) injection ................................. 1233Sodium iodohippurate (131I) injection ................................. 1234Sodium iodohippurate dihydrate for radiopharmaceuticalpreparations .......................................................................... 1234

Sodium lactate solution ................................................10.4-5564Sodium laurilsulfate ......................................................10.3-5134Sodium lauroylsarcosinate for external use......................... 3828Sodium metabisulfite ....................................................10.3-5135Sodium methyl parahydroxybenzoate ................................. 3830Sodium molybdate (99Mo) solution (fission) ...................... 1235Sodium molybdate dihydrate ................................................ 3831Sodium nitrite ......................................................................... 3832Sodium nitroprusside............................................................. 3832Sodium perborate, hydrated.................................................. 3833Sodium pertechnetate (99mTc) injection (accelerator-produced) .............................................................................. 1237

Sodium pertechnetate (99mTc) injection (fission) ............... 1238Sodium pertechnetate (99mTc) injection (non-fission) ....... 1240Sodium phenylbutyrate.......................................................... 3833Sodium phosphate (32P) injection......................................... 1240Sodium picosulfate ................................................................. 3835Sodium polystyrene sulfonate ............................................... 3836Sodium propionate ................................................................. 3837Sodium propyl parahydroxybenzoate .................................. 3838Sodium pyrophosphate decahydrate for radiopharmaceuticalpreparations .......................................................................... 1241

Sodium risedronate 2.5-hydrate ........................................... 3729Sodium salicylate .................................................................... 3839Sodium selenite....................................................................... 3840Sodium selenite pentahydrate ............................................... 3840Sodium (S)-lactate solution..........................................10.4-5565Sodium starch glycolate (type A).......................................... 3841Sodium starch glycolate (type B) .......................................... 3842Sodium starch glycolate (type C).......................................... 3843Sodium stearate....................................................................... 3844Sodium stearyl fumarate........................................................ 3845Sodium sulfate, anhydrous .................................................... 3846Sodium sulfate decahydrate..........................................10.1-4493Sodium sulfite ......................................................................... 3847Sodium sulfite heptahydrate.................................................. 3848Sodium tetrachloroaurate dihydrate for homoeopathicpreparations .......................................................................... 1704

Sodium thiosulfate.................................................................. 3848Sodium valproate.................................................................... 3849Soft capsules .............................................................................. 906Soft extracts ............................................................................... 867Softening time determination of lipophilic suppositories(2.9.22.) .................................................................................... 363

Solid dosage forms, dissolution test for (2.9.3.).................... 326Solid dosage forms, recommendations on dissolution testingof (5.17.1.)................................................................................ 801

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.) .......................................................... 377

Solids, density of (2.2.42.).......................................................... 76Solids, gas pycnometric density of (2.9.23.) .......................... 364Solids (porous) including powders, wettability of (2.9.45.).. 406Solifenacin succinate .............................................................. 3850Solubility in alcohol of essential oils (2.8.10.) ....................... 306Soluble tablets ........................................................................... 939Solution calorimetry and microcalorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 115

Solutions, emulsions and suspensions, oral .......................... 917Solutions for haemodialysis................................................... 2798Solutions for haemodialysis, concentrated, water fordiluting................................................................................... 2797

Solutions for haemofiltration and haemodiafiltration ....... 2803Solutions for organ preservation .................................10.3-5135Solutions for peritoneal dialysis............................................ 3515Solutions, oromucosal ...................................................10.3-4826Solutions, suspensions, intrauterine....................................... 914Solvents, residual (5.4.) ............................................................ 717Solvents, residual, identification and control of(2.4.24.) .........................................................................10.1-4323

Somatostatin............................................................................ 3853Somatropin .............................................................................. 3854Somatropin concentrated solution ....................................... 3856Somatropin for injection ....................................................... 3858Somatropin solution for injection ........................................ 3860Sophora flower ........................................................................ 1626Sophora flower-bud................................................................ 1628Sorafenib tablets.............................................................10.4-5567Sorafenib tosilate ...........................................................10.4-5566Sorbic acid ............................................................................... 3861Sorbitan laurate....................................................................... 3862Sorbitan oleate......................................................................... 3862Sorbitan palmitate .................................................................. 3863Sorbitan sesquioleate.............................................................. 3863Sorbitan stearate ..................................................................... 3864Sorbitan trioleate .................................................................... 3865Sorbitol..................................................................................... 3865Sorbitol, liquid (crystallising) ............................................... 3867Sorbitol, liquid (non-crystallising) ....................................... 3867Sorbitol, liquid, partially dehydrated ................................... 3868Sorption-desorption isotherms and water activity,determination of (water-solid interactions) (2.9.39.)......... 394

Sotalol hydrochloride....................................................10.3-5136Soya phospholipids for injection .......................................... 3870Soya-bean oil, hydrogenated ................................................. 3872Soya-bean oil, refined............................................................. 3873Spanish sage oil ....................................................................... 1629Specific surface area by air permeability (2.9.14.) ................ 343Specific surface area by gas adsorption (2.9.26.) .................. 369Spectinomycin dihydrochloride pentahydrate.................... 3873Spectinomycin sulfate tetrahydrate for veterinary use....... 3875Spectrometry, atomic absorption (2.2.23.) .............................. 37Spectrometry, atomic emission (2.2.22.) ................................. 36Spectrometry, mass (2.2.43.) ..................................................... 77Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 58Spectrometry, X-ray fluorescence (2.2.37.) ............................. 65Spectrophotometry, infrared absorption (2.2.24.) ....10.3-4753Spectrophotometry, ultraviolet and visible absorption(2.2.25.) ...................................................................................... 42

Spectroscopy, near-infrared (2.2.40.) ....................................... 70Spectroscopy, Raman (2.2.48.).................................................. 92SPF chicken flocks for the production and quality control ofvaccines (5.2.2.)....................................................................... 647

Spheroids and granules, friability of (2.9.41.) ....................... 400Spike lavender oil.................................................................... 1630Spiramycin......................................................................10.3-5137Spirapril hydrochloride monohydrate ................................. 3880Spironolactone ........................................................................ 3881Spot-on preparations................................................................ 942Sprays, nasal ...................................................................10.3-4824Sprays, oromucosal ........................................................10.3-4827



Sprays, veterinary ..................................................................... 942Squalane..........................................................................10.1-4493Squalene................................................................................... 3886St. John’s wort.......................................................................... 1631St. John’s wort dry extract, quantified.................................. 1633Standard solutions for limit tests (4.1.2.)....................10.4-5349Standards, reference (5.12.) ..................................................... 773Stannous chloride dihydrate.................................................. 3886Stanozolol .......................................................................10.3-5140Staphysagria for homoeopathic preparations ..................... 1726Star anise.................................................................................. 1635Star anise oil ............................................................................ 1636Starch glycolate (type A), sodium......................................... 3841Starch glycolate (type B), sodium ......................................... 3842Starch glycolate (type C), sodium......................................... 3843Starch, hydroxypropyl ............................................................ 3888Starch, hydroxypropyl, pregelatinised.................................. 3890Starch, maize ........................................................................... 3167Starch, pea ............................................................................... 3492Starch, potato .......................................................................... 3611Starch, pregelatinised ............................................................. 3891Starch, rice ............................................................................... 3721Starch, wheat ..................................................................10.3-5161Starches, hydroxyethyl ........................................................... 3892Starflower (borage) oil, refined ............................................. 1992Statistical analysis of results of biological assays and tests(5.3.) ......................................................................................... 685

Statistical process control, multivariate (5.28.) ..........10.4-5377Stavudine ................................................................................. 3896Stearic acid......................................................................10.4-5569Stearoyl macrogolglycerides .................................................. 3899Stearyl alcohol ......................................................................... 3900Stem cells, human haematopoietic ....................................... 2857Stephania root, fourstamen ................................................... 1438Sterile braided silk suture in distributor for veterinaryuse........................................................................................... 1283

Sterile catgut ............................................................................ 1269Sterile catgut in distributor for veterinary use.................... 1281Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.3.6.) ............... 474

Sterile linen thread in distributor for veterinary use ......... 1282Sterile non-absorbable strands in distributor for veterinaryuse........................................................................................... 1283

Sterile non-absorbable sutures .............................................. 1270Sterile plastic containers for human blood and bloodcomponents (3.3.4.).....................................................10.3-4791

Sterile polyamide suture in distributor for veterinary use.. 1282Sterile poly(ethylene terephthalate) suture in distributor forveterinary use........................................................................ 1283

Sterile products, biological indicators and related microbialpreparations used in the manufacture of (5.1.2.) ............... 622

Sterile products, methods of preparation of (5.1.1.) ............ 619Sterile single-use plastic syringes (3.3.8.) ...................10.3-4792Sterile synthetic absorbable braided sutures ....................... 1274Sterile synthetic absorbable monofilament sutures ............ 1275Sterility (2.6.1.).......................................................................... 191Sterility, guidelines for using the test for (5.1.9.).................. 639Sterols in fatty oils (2.4.23.) ..................................................... 150Sticks .......................................................................................... 937Sticks, intrauterine.................................................................... 914Sticks, nasal ....................................................................10.3-4825Stomata and stomatal index (2.8.3.) ....................................... 305Stramonium leaf ..................................................................... 1638Stramonium, prepared ........................................................... 1640Strands, sterile non-absorbable, in distributor for veterinaryuse .......................................................................................... 1283

Streptokinase concentrated solution .................................... 3901Streptomycin sulfate ......................................................10.3-5141Strontium (89Sr) chloride injection....................................... 1242Strychnos ignatii for homoeopathic preparations .............. 1719Subdivision of tablets ............................................................... 937Sublingual sprays ...........................................................10.3-4827Sublingual tablets and buccal tablets...........................10.3-4828

Substances for pharmaceutical use ..............................10.3-4817Substances for pharmaceutical use, control of impurities in(5.10.) ....................................................................................... 763

Substitution of in vivo method(s) by in vitro method(s) for thequality control of vaccines (5.2.14.) ..................................... 679

Sub-visible particles, particulate contamination(2.9.19.) .........................................................................10.3-4785

Sucralfate ................................................................................. 3904Sucralose .................................................................................. 3905Sucrose ..................................................................................... 3906Sucrose, liquid......................................................................... 3908Sucrose monopalmitate.......................................................... 3909Sucrose stearate....................................................................... 3911Sufentanil ................................................................................. 3912Sufentanil citrate ..................................................................... 3913Sugar spheres........................................................................... 3915Sugars, lead in (2.4.10.) ............................................................ 142Sulbactam sodium .................................................................. 3915Sulfacetamide sodium............................................................ 3917Sulfadiazine ............................................................................. 3918Sulfadimethoxine.................................................................... 3920Sulfadimethoxine sodium for veterinary use ...................... 3921Sulfadimidine .......................................................................... 3922Sulfadoxine .............................................................................. 3924Sulfafurazole............................................................................ 3925Sulfaguanidine ........................................................................ 3926Sulfamerazine.......................................................................... 3926Sulfamethizole................................................................10.1-4494Sulfamethoxazole.................................................................... 3928Sulfamethoxypyridazine for veterinary use......................... 3929Sulfanilamide........................................................................... 3930Sulfasalazine ............................................................................ 3931Sulfated ash (2.4.14.) ................................................................ 142Sulfates (2.4.13.)........................................................................ 142Sulfathiazole ............................................................................ 3933Sulfinpyrazone......................................................................... 3934Sulfobutylbetadex sodium ............................................10.3-5143Sulfur ..............................................................................10.3-5145Sulfur dioxide (2.5.29.)..................................................10.4-5227Sulfur for homoeopathic preparations................................. 1727Sulfuric acid....................................................................10.3-5146Sulindac.................................................................................... 3939Sulpiride................................................................................... 3940Sultamicillin ............................................................................ 3941Sultamicillin tosilate dihydrate ............................................. 3944Sumatra benzoin..................................................................... 1341Sumatra benzoin tincture ...................................................... 1343Sumatriptan succinate............................................................ 3946Sunflower oil, refined ............................................................. 3948Supercritical fluid chromatography (2.2.45.) .......................... 80Suppositories ............................................................................. 934Suppositories and pessaries, disintegration of (2.9.2.) ......... 325Suppositories, lipophilic, softening time determination(2.9.22.) .................................................................................... 363

Suspensions, oromucosal ..............................................10.3-4826Suspensions, solutions and emulsions, oral .......................... 917Suspensions, solutions, intrauterine....................................... 914Sutures for human use : introduction..........................10.1-4349Sutures, sterile non-absorbable ............................................. 1270Sutures, sterile synthetic absorbable braided ..................... 1274Sutures, sterile synthetic absorbable monofilament .......... 1275Suxamethonium chloride ...................................................... 3948Suxibuzone .............................................................................. 3949Sweet fennel............................................................................. 1434Sweet orange oil ...................................................................... 1641Swelling index (2.8.4.) .............................................................. 306Swine erysipelas vaccine (inactivated) ................................. 1158Swine-fever vaccine (live, prepared in cell cultures),classical .........................................................................10.2-4667

Symbols and abbreviations (1.) ................................................... 3Synthetic absorbable braided sutures, sterile ...................... 1274Synthetic absorbable monofilament sutures, sterile ........... 1275Syringes, plastic, sterile single-use (3.3.8.) .................10.3-4792



Syrups......................................................................................... 918Szechwan lovage rhizome ...................................................... 1642

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.)..................................... 745

Tablets ........................................................................................ 937Tablets and capsules, disintegration of (2.9.1.) ..................... 323Tablets and powders for rectal solutions and suspensions .. 934Tablets, buccal ................................................................10.3-4828Tablets, buccal, mucoadhesive .....................................10.3-4828Tablets, chewable ...................................................................... 939Tablets, coated........................................................................... 938Tablets, dispersible.................................................................... 939Tablets, effervescent.................................................................. 939Tablets for intrauterine solutions and suspensions .............. 914Tablets for vaginal solutions and suspensions ...................... 941Tablets, gastro-resistant............................................................ 938Tablets, intrauterine.................................................................. 914Tablets, modified-release ......................................................... 939Tablets, orodispersible.............................................................. 939Tablets, resistance to crushing (2.9.8.) ................................... 337Tablets, soluble .......................................................................... 939Tablets, subdivision of.............................................................. 937Tablets, sublingual .........................................................10.3-4828Tablets, uncoated ...................................................................... 938Tablets, uncoated, friability of (2.9.7.) ................................... 336Tablets, vaginal.......................................................................... 941Tacalcitol monohydrate.......................................................... 3953Tacrolimus monohydrate....................................................... 3954Tadalafil.................................................................................... 3957Talc ........................................................................................... 3959Tamoxifen citrate .................................................................... 3961Tampons, ear ............................................................................. 909Tampons, medicated ............................................................... 940Tampons, rectal......................................................................... 935Tampons, vaginal, medicated.................................................. 941Tamsulosin hydrochloride..................................................... 3963Tannic acid .............................................................................. 3964Tannins in herbal drugs (2.8.14.)............................................ 310Tapentadol hydrochloride ..................................................... 3965Tapped density and bulk density of powders (2.9.34.)......... 384Tartaric acid............................................................................. 3966Tea tree oil ............................................................................... 1643Teat dips ..................................................................................... 942Teat sprays ................................................................................. 942Technetium (99mTc) bicisate injection .................................. 1243Technetium (99mTc) colloidal rhenium sulfide injection ... 1244Technetium (99mTc) colloidal sulfur injection ..................... 1244Technetium (99mTc) colloidal tin injection .......................... 1245Technetium (99mTc) etifenin injection.................................. 1246Technetium (99mTc) exametazime injection ........................ 1247Technetium (99mTc) gluconate injection .............................. 1248Technetium (99mTc) human albumin injection ................... 1249Technetium (99mTc) macrosalb injection ............................. 1251Technetium (99mTc) mebrofenin injection ..................10.1-4345Technetium (99mTc) medronate injection ............................ 1253Technetium (99mTc) mertiatide injection ............................. 1254Technetium (99mTc) microspheres injection ........................ 1255Technetium (99mTc) oxidronate injection ............................ 1256Technetium (99mTc) pentetate injection ............................... 1257Technetium (99mTc) sestamibi injection............................... 1258Technetium (99mTc) succimer injection................................ 1259Technetium (99mTc) tin pyrophosphate injection ............... 1260Teicoplanin .............................................................................. 3967Telmisartan.............................................................................. 3970Temazepam.............................................................................. 3972Temozolomide......................................................................... 3973Tenosynovitis vaccine (live), viral, avian ....................10.2-4632Tenoxicam ............................................................................... 3974Terazosin hydrochloride dihydrate ...................................... 3976Terbinafine hydrochloride ..................................................... 3978

Terbutaline sulfate .................................................................. 3979Terconazole.............................................................................. 3980Terfenadine.............................................................................. 3982Teriparatide ............................................................................. 3983Terlipressin .............................................................................. 3986Terminology used in monographs on biological products(5.2.1.) ...................................................................................... 647

Terpin monohydrate............................................................... 3988Test for anticomplementary activity of immunoglobulin(2.6.17.) .................................................................................... 216

Test for anti-D antibodies in human immunoglobulin(2.6.26.) .................................................................................... 230

Test for aristolochic acids in herbal drugs (2.8.21) .............. 314Test for bacterial endotoxins using recombinant factor C(2.6.32.) .........................................................................10.3-4776

Test for extractable volume of parenteral preparations(2.9.17.) .................................................................................... 347

Test for Fc function of immunoglobulin (2.7.9.) .................. 279Test for methanol and 2-propanol (2.9.11.) .......................... 342Test for neurovirulence of live virus vaccines (2.6.18.)........ 218Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) ........10.3-4769

Testosterone....................................................................10.1-4499Testosterone decanoate .......................................................... 3991Testosterone enantate ............................................................. 3992Testosterone isocaproate ........................................................ 3994Testosterone propionate......................................................... 3995Tests for extraneous agents in viral vaccines for human use(2.6.16.) .........................................................................10.2-4579

Tests for specified micro-organisms (microbiologicalexamination of live biotherapeutic products) (2.6.38.)...... 255

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 295

Tetanus and diphtheria vaccine (adsorbed) ...............10.3-4831Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content).........................................................................10.3-4831

Tetanus antitoxin for human use .......................................... 1173Tetanus antitoxin for veterinary use..................................... 1177Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed) ....................................................................10.3-4832

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed) ......................................................10.3-4834

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)......10.3-4835

Tetanus, diphtheria and pertussis (whole cell) vaccine(adsorbed) ....................................................................10.3-4836

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)....................10.3-4838

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4839

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ....................10.3-4841

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)........10.3-4843

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ......................................................10.3-4844

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..10.3-4846

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ......................................................10.3-4849

Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) ...............................10.3-4851

Tetanus, diphtheria, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ....................................................................10.3-4853

Tetanus immunoglobulin, human ........................................ 2873Tetanus vaccine (adsorbed) ..........................................10.3-4855Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 275Tetanus vaccine for veterinary use........................................ 1161Tetanus vaccine for veterinary use ..............................10.3-4859



Tetracaine ................................................................................ 3997Tetracaine hydrochloride....................................................... 3998Tetracosactide.......................................................................... 3999Tetracycline ............................................................................. 4000Tetracycline hydrochloride.................................................... 4001Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations .......................................................................... 1261

Tetrazepam .............................................................................. 4003Tetryzoline hydrochloride ..................................................... 4004Thallous (201Tl) chloride injection ........................................ 1262Theobromine........................................................................... 4005Theophylline ........................................................................... 4005Theophylline monohydrate ................................................... 4007Theophylline-ethylenediamine ............................................. 4008Theophylline-ethylenediamine hydrate ............................... 4009Thermal analysis (2.2.34.).......................................................... 61Thermogravimetry (2.2.34.) ...................................................... 61Thiamazole .............................................................................. 4011Thiamine hydrochloride ........................................................ 4012Thiamine nitrate ..................................................................... 4014Thiamphenicol ........................................................................ 4015Thin-layer chromatography (2.2.27.) ....................................... 47Thiocolchicoside crystallised from ethanol ........................ 4016Thiocolchicoside hydrate..............................................10.1-4500Thioctic acid............................................................................ 4020Thiomersal............................................................................... 4021Thiopental sodium and sodium carbonate ......................... 4022Thioridazine ............................................................................ 4024Thioridazine hydrochloride .................................................. 4025Thomson kudzuvine root ...................................................... 1644Three-lobed sage leaf ............................................................. 1608Threonine ................................................................................ 4027Thyme ...................................................................................... 1646Thyme oil, thymol type.......................................................... 1648Thyme, wild............................................................................. 1669Thymol..................................................................................... 4028Thymol type thyme oil........................................................... 1648Tiabendazole ........................................................................... 4029Tiamulin for veterinary use................................................... 4030Tiamulin hydrogen fumarate for veterinary use................. 4032Tianeptine sodium.................................................................. 4035Tiapride hydrochloride .......................................................... 4036Tiaprofenic acid .............................................................10.1-4503Tibolone................................................................................... 4039Ticagrelor........................................................................10.4-5573Ticarcillin sodium .................................................................. 4040Tick-borne encephalitis vaccine (inactivated) .................... 1043Ticlopidine hydrochloride ..................................................... 4041Tigecycline......................................................................10.4-5574Tilidine hydrochloride hemihydrate ...........................10.3-5149Timolol maleate ...................................................................... 4046Tinctures .................................................................................... 867Tinidazole ................................................................................ 4048Tinnevelly senna pods...................................................10.1-4363Tinzaparin sodium ................................................................. 4049Tioconazole ............................................................................. 4050Tiotropium bromide monohydrate ...................................... 4051Titanium dioxide .................................................................... 4052Titration, amperometric (2.2.19.) ............................................. 35Titration, potentiometric (2.2.20.)............................................ 35Titration, voltametric (2.2.65.)................................................ 119Titrations, complexometric (2.5.11.)...................................... 170Tizanidine hydrochloride ...................................................... 4053Tobramycin.............................................................................. 4055Tocopherol, all-rac-α-............................................................. 4057Tocopherol, RRR-α-................................................................ 4058Tocopheryl acetate, all-rac-α- ............................................... 4059α-Tocopheryl acetate concentrate (powder form) .............. 4062Tocopheryl acetate, RRR-α-................................................... 4060Tocopheryl hydrogen succinate, DL-α- ................................ 4062Tocopheryl hydrogen succinate, RRR-α- ............................. 4064Tolbutamide............................................................................. 4066Tolfenamic acid....................................................................... 4067

Tolnaftate ................................................................................. 4068Tolterodine tartrate................................................................. 4070Tolu balsam ............................................................................. 1649Toluenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.40.)................................................................. 185

Topiramate............................................................................... 4071Torasemide .............................................................................. 4073Tormentil ................................................................................. 1650Tormentil tincture .................................................................. 1650Tosylchloramide sodium ....................................................... 4074Total ash (2.4.16.)...................................................................... 143Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 163Total organic carbon in water for pharmaceutical use(2.2.44.) ...................................................................................... 79

Total protein (2.5.33.)............................................................... 178Traditional Chinese medicine, names of herbal drugs used in(5.22.) ............................................................................10.4-5367

Tragacanth ............................................................................... 1651Tramadol hydrochloride ...............................................10.3-5150Tramazoline hydrochloride monohydrate..................10.3-5151Trandolapril............................................................................. 4077Tranexamic acid.............................................................10.1-4504Transdermal patches ................................................................ 925Transdermal patches, dissolution test for (2.9.4.)................. 333Trapidil..................................................................................... 4079Trehalose dihydrate ................................................................ 4080Tretinoin .................................................................................. 4082Triacetin ................................................................................... 4083Triamcinolone ......................................................................... 4083Triamcinolone acetonide ....................................................... 4085Triamcinolone hexacetonide ................................................. 4086Triamterene ............................................................................. 4088Tribenoside.............................................................................. 4089Tributyl acetylcitrate............................................................... 4090Trichloroacetic acid ................................................................ 4092Triclabendazole for veterinary use ....................................... 4093Triethanolamine...................................................................... 4106Triethyl citrate ......................................................................... 4094Trifluoperazine hydrochloride .............................................. 4095Trifluridine .....................................................................10.3-5152Triflusal .................................................................................... 4095Triglycerides, medium-chain ................................................ 4096Triglycerides, omega-3-acid .........................................10.3-5084Triglycerol diisostearate ......................................................... 4097Trihexyphenidyl hydrochloride ............................................ 4098Trimebutine maleate .............................................................. 4099Trimeprazine hemitartrate .................................................... 1782Trimetazidine dihydrochloride ............................................. 4100Trimethadione......................................................................... 4101Trimethoprim.......................................................................... 4102Trimipramine maleate............................................................ 4104Tri-n-butyl phosphate ............................................................ 4091Tritiated (3H) water injection ................................................ 1263Trolamine................................................................................. 4106Trometamol ............................................................................. 4107Tropicamide............................................................................. 4108Tropisetron hydrochloride..................................................... 4110Trospium chloride .................................................................. 4111Troxerutin................................................................................ 4112Trypsin ............................................................................10.4-5576Tryptophan .............................................................................. 4115TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ......................... 661

TSE, animal, products with risk of transmitting agents of.. 884Tuberculin for human use, old.............................................. 4117Tuberculin purified protein derivative, avian ..................... 4119Tuberculin purified protein derivative, bovine ................... 4120Tuberculin purified protein derivative for human use....... 4120Tuberculosis (BCG) vaccine, freeze-dried............................. 949Tubes for comparative tests (2.1.5.).......................................... 17Tubing and closures, silicone elastomer for (3.1.9.) ............. 436Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434



Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.3.3.) ............................................................... 468

Turkey infectious rhinotracheitis vaccine (live) ........10.2-4668Turmeric, Javanese.................................................................. 1652Turmeric rhizome................................................................... 1653Turpentine oil.......................................................................... 1655Tylosin for veterinary use ...................................................... 4122Tylosin phosphate bulk solution for veterinary use ........... 4127Tylosin phosphate for veterinary use ................................... 4131Tylosin tartrate for veterinary use ........................................ 4136Typhae pollen.......................................................................... 1656Typhoid polysaccharide and hepatitis A (inactivated,adsorbed) vaccine ................................................................... 982

Typhoid polysaccharide vaccine ........................................... 1044Typhoid vaccine ...................................................................... 1046Typhoid vaccine (live, oral, strain Ty 21a) .......................... 1046Tyrosine ................................................................................... 4140Tyrothricin............................................................................... 4142

UUbidecarenone ........................................................................ 4147Udder-washes............................................................................ 942Ultraviolet and visible absorption spectrophotometry(2.2.25.) ...................................................................................... 42

Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15Uncaria stem with hooks ....................................................... 1657Uncoated tablets ....................................................................... 938Undecylenic acid..................................................................... 4148Uniformity of content of single-dose preparations (2.9.6.).. 336Uniformity of dosage units (2.9.40.)....................................... 398Uniformity of dosage units, demonstration using large samplesizes (2.9.47.) ........................................................................... 409

Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) ................................................................. 372

Uniformity of mass of single-dose preparations (2.9.5.) ..... 335Units of the International System (SI) used in thePharmacopoeia and equivalence with other units (1.) .......... 3

Unsaponifiable matter (2.5.7.)................................................. 169Urea .......................................................................................... 4149Urofollitropin .......................................................................... 4149Urokinase................................................................................. 4151Uronic acids in polysaccharide vaccines (2.5.22.) ................ 174Ursodeoxycholic acid ............................................................ 4152Urtica dioica for homoeopathic preparations..................... 1728

VVaccine component assay by immunonephelometry(2.7.35.) .................................................................................... 301

Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 171Vaccines, adsorbed, calcium in (2.5.14.)................................ 172Vaccines and immunosera, phenol in (2.5.15.)..................... 172Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 661

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 658

Vaccines for human use ........................................................... 893Vaccines for human use, cell substrates for the production of(5.2.3.) ...................................................................................... 650

Vaccines for human use, conjugated polysaccharide, carrierproteins for the production of (5.2.11.) ............................... 674

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) .........................................................................10.2-4579

Vaccines for veterinary use...........................................10.2-4604Vaccines for veterinary use, inactivated, healthy chicken flocksfor the production of (5.2.13.) ...................................10.2-4598

Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 173Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 173Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 172Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 173Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 172Vaccines, polysaccharide, protein in (2.5.16.) ....................... 172

Vaccines, polysaccharide, ribose in (2.5.31.)......................... 177Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 174Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 174Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ................................................................... 647

Vaccines, substitution of in vivo method(s) by in vitromethod(s) for the quality control of (5.2.14.) ..................... 679

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ...........................................................................10.2-4589

Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 218Vaginal capsules ........................................................................ 941Vaginal foams............................................................................ 941Vaginal preparations ................................................................ 940Vaginal preparations, semi-solid ............................................ 941Vaginal solutions and suspensions, tablets for...................... 941Vaginal solutions, emulsions and suspensions...................... 941Vaginal tablets ........................................................................... 941Vaginal tampons, medicated ................................................... 941Valaciclovir hydrochloride .................................................... 4157Valaciclovir hydrochloride hydrate ...................................... 4160Valerian dry aqueous extract ............................................... 1659Valerian dry hydroalcoholic extract ..................................... 1660Valerian root............................................................................ 1660Valerian root, cut .................................................................... 1662Valerian tincture ..................................................................... 1664Validation of nucleic acid amplification techniques for thedetection of B19 virus (B19V) DNA in plasma pools :guidelines................................................................................. 219

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines................................................................................. 219

Valine ....................................................................................... 4162Valnemulin hydrochloride for veterinary use .................... 4164Valproate, sodium................................................................... 3849Valproic acid............................................................................ 4165Valsartan .................................................................................. 4167Vancomycin hydrochloride ..........................................10.4-5581Vanillin..................................................................................... 4172Vapour, preparations to be converted into............................ 928Vardenafil hydrochloride trihydrate..................................... 4172Varicella immunoglobulin for intravenous administration,human .................................................................................... 2875

Varicella immunoglobulin, human ...................................... 2875Varicella, measles, mumps and rubella vaccine (live) ........ 1006Varicella vaccine (live) ........................................................... 1048Vectors for human use, adeno-associated-virus ................... 788Vectors for human use, adenovirus ........................................ 782Vectors for human use, plasmid ............................................. 780Vectors for human use, plasmid, bacterial cells used for themanufacture of........................................................................ 781

Vectors for human use, poxvirus ............................................ 784Vectors for human use, retroviridae-derived ........................ 786Vecuronium bromide ............................................................. 4173Vedaprofen for veterinary use............................................... 4175Vegetable fatty oils .................................................................... 901Venlafaxine hydrochloride .................................................... 4176Verapamil hydrochloride ....................................................... 4178Verbena herb ........................................................................... 1665Veterinary liquid preparations for cutaneous application... 941Veterinary medicinal products, immunological, managementof extraneous agents in (5.2.5.) ..................................10.2-4590

Veterinary semi-solid preparations for oral use ................... 942Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.) ...................................................................................... 661

Viability, nucleated cell count and (2.7.29.) .......................... 297Vibriosis (cold-water) vaccine (inactivated) forsalmonids............................................................................... 1163

Vibriosis vaccine (inactivated) for salmonids ..................... 1164VICH (5.8.)................................................................................ 755Vigabatrin ................................................................................ 4180Vinblastine sulfate .................................................................. 4181Vincamine.......................................................................10.4-5584Vincristine sulfate ................................................................... 4183



Vindesine sulfate..................................................................... 4185Vinorelbine tartrate ................................................................ 4186Vinpocetine ............................................................................. 4188Viper venom antiserum, European ...................................... 1174Viral diarrhoea vaccine (inactivated), bovine ..................... 1075Viral hepatitis type I vaccine (live), duck ...................10.2-4647Viral rhinotracheitis vaccine (inactivated), feline .............. 1113Viral rhinotracheitis vaccine (live), feline ..................10.2-4652Viral safety (5.1.7.).................................................................... 637Viral tenosynovitis vaccine (live), avian .....................10.2-4632Viral vaccines for human use, tests for extraneous agents in(2.6.16.) .........................................................................10.2-4579

Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer methods, falling ball and automatic rolling ball(2.2.49.) .........................................................................10.3-4761

Viscose wadding, absorbent .................................................. 4189Viscosity - rotating viscometer method (2.2.10.) ................... 28Viscosity (2.2.8.).......................................................................... 27Visible and ultraviolet absorption spectrophotometry(2.2.25.) ...................................................................................... 42

Visible particles, particulate contamination (2.9.20.) .......... 362Visible particles, recommendations on testing of particulatecontamination (5.17.2.)...............................................10.3-4809

Vitamin A ................................................................................ 4191Vitamin A concentrate (oily form), synthetic ............10.3-5157Vitamin A concentrate (powder form), synthetic .............. 4193Vitamin A concentrate (solubilisate/emulsion),synthetic................................................................................. 4194

Voltametric titration (2.2.65.) ................................................. 119Volumetric analysis (4.2.) .............................................10.4-5360Volumetric solutions (4.2.2.) ........................................10.4-5360Volumetric solutions, primary standards for (4.2.1.)........ 10.4-5360

von Willebrand factor, human.............................................. 2875von Willebrand factor, human, assay of (2.7.21.) ................. 290Voriconazole............................................................................ 4196

WWarfarin sodium..................................................................... 4201Warfarin sodium clathrate..................................................... 4202Washes, nasal..................................................................10.3-4825Water (15O) injection .............................................................. 1264Water activity and sorption-desorption isotherms,determination of (water-solid interactions) (2.9.39.)......... 394

Water, determination by distillation (2.2.13.) ......................... 31Water for diluting concentrated haemodialysis solutions.. 2797Water for injections ................................................................ 4203Water for pharmaceutical use, total organic carbon in(2.2.44.) ...................................................................................... 79

Water for preparation of extracts.......................................... 4206Water in essential oils (2.8.5.) ................................................. 306Water in gases (2.5.28.) ............................................................ 176Water : micro determination (2.5.32.) .................................... 178Water, purified ........................................................................ 4207Water : semi-micro determination (2.5.12.) .......................... 171Water-solid interactions : determination of sorption-desorption isotherms and of water activity (2.9.39.) ......... 394

Wettability of porous solids including powders (2.9.45.) .... 406Wheat starch...................................................................10.3-5161Wheat-germ oil, refined......................................................... 4210

Wheat-germ oil, virgin........................................................... 4210White beeswax ........................................................................ 1931White horehound ................................................................... 1667White peony root.................................................................... 1573White soft paraffin.................................................................. 3485Wild pansy (flowering aerial parts) ...................................... 1668Wild thyme.............................................................................. 1669Willow bark ............................................................................. 1671Willow bark dry extract ......................................................... 1672Wool alcohols .................................................................10.3-5162Wool fat.................................................................................... 4211Wool fat, hydrogenated.......................................................... 4215Wool fat, hydrous.................................................................... 4216Wormwood.............................................................................. 1673

XXanthan gum........................................................................... 4221Xenon (133Xe) injection .......................................................... 1264X-ray fluorescence spectrometry (2.2.37.)............................... 65X-ray powder diffraction (XRPD), characterisation ofcrystalline and partially crystalline solids by (2.9.33.)....... 379

Xylazine hydrochloride for veterinary use .................10.4-5589Xylitol ....................................................................................... 4223Xylometazoline hydrochloride.....................................10.1-4509Xylose ....................................................................................... 4226

YYarrow ...................................................................................... 1674Yeasticidal, bactericidal or fungicidal activity of antisepticmedicinal products, determination of (5.1.11.) .................. 643

Yellow beeswax........................................................................ 1932Yellow fever vaccine (live) ............................................10.2-4613Yellow soft paraffin................................................................. 3486Yersiniosis vaccine (inactivated) for salmonids .................. 1102Yohimbine hydrochloride ...................................................... 4231Yttrium (90Y) chloride solution for radiolabelling.............. 1265

ZZanamivir hydrate .........................................................10.1-4513Zanthoxylum bungeanum pericarp.............................10.4-5411Zidovudine .............................................................................. 4236Zinc acetate dihydrate ............................................................ 4238Zinc acexamate ..............................................................10.3-5165Zinc chloride ........................................................................... 4241Zinc gluconate......................................................................... 4241Zinc oxide ................................................................................ 4242Zinc stearate ............................................................................ 4242Zinc sulfate heptahydrate ...................................................... 4243Zinc sulfate hexahydrate ........................................................ 4244Zinc sulfate monohydrate...................................................... 4244Zinc undecylenate .................................................................. 4244Ziprasidone hydrochloride monohydrate............................ 4245Ziprasidone mesilate trihydrate ............................................ 4247Zoledronic acid monohydrate......................................10.1-4514Zolmitriptan ............................................................................ 4251Zolpidem tartrate...........................................................10.1-4516Zopiclone ................................................................................. 4254Zoster (shingles) vaccine (live), herpes................................ 1036Zuclopenthixol decanoate.............................................10.4-5593


EUROPEANPHARMACOPOEIA10.4 INDEX...EUROPEANPHARMACOPOEIA10.4 Index Index Altizide

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