Compendial Deferrals for USP42-NF37 1S · pharmaceutical compounding--nonsterile preparations pf...
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Compendial Deferrals for USP42-NF37 1S Category Monograph Title Monograph Section Scientific Liaison Revision EXCIPIENTS (USP and NF), LISTED BY CATEGORY PF 42(2) Pg. ONLINE {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF, {Flavors and Fragrance} Anise Oil, {Flavors and Fragrance} Star Anise Oil Hong Wang Revision GENERAL NOTICES TO USP-NF PF 44(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Guanidine Hydrochloride, Gadobutrol, Rotigotine, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Neohesperidin Dihydrochalcone, Tetrabenazine, Anise Oil, Choline Fenofibrate, Nisoldipine, Star Anise Oil Sujatha Ramakrishna New <64> PROBIOTIC TESTS PF 43(2) Pg. ONLINE Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE ??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine and Insulin Lispro Diane McCarthy New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Elena Curti New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINE DEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa Revision <671> CONTAINERS--PERFORMANCE TESTING PF 44(3) Pg. ONLINE Introduction, INTRODUCTION, MOISTURE VAPOR TRANSMISSION FOR PLASTIC PACKAGING SYSTEMS, CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS, SPECTRAL TRANSMISSION Desmond Hunt Revision <701> DISINTEGRATION PF 44(2) Pg. ONLINE APPARATUS William Brown Revision <795> PHARMACEUTICAL COMPOUNDING--NONSTERILE PREPARATIONS PF 44(3) Pg. ONLINE Introduction, INTRODUCTION, CATEGORIES OF COMPOUNDING, RESPONSIBILITIES OF THE COMPOUNDER, COMPOUNDING PROCESS, COMPOUNDING FACILITIES, COMPOUNDING EQUIPMENT, COMPONENT SELECTION, HANDLING, AND STORAGE, STABILITY CRITERIA AND BEYOND-USE DATING, PACKAGING AND DRUG PREPARATION CONTAINERS, COMPOUNDING DOCUMENTATION, QUALITY CONTROL, PATIENT COUNSELING, TRAINING, COMPOUNDING FOR ANIMAL PATIENTS, GLOSSARY, 1. INTRODUCTION AND SCOPE, 2. PERSONNEL QUALIFICATIONS- TRAINING, EVALUATION, AND REQUALIFICATION, 3. PERSONAL HYGIENE AND GARBING, 4. BUILDINGS AND FACILITIES, 5. CLEANING AND SANITIZING, 6. EQUIPMENT AND COMPONENTS, 7. SOPS AND MASTER FORMULATION AND COMPOUNDING RECORDS, 8. RELEASE TESTING, 9. LABELING, 10. ESTABLISHING BEYOND-USE DATES, 11. QUALITY ASSURANCE AND QUALITY CONTROL, 12. CNSP HANDLING, PACKAGING, STORAGE, AND TRANSPORT, 13. COMPLAINT HANDLING AND ADVERSE EVENT REPORTING, 14. DOCUMENTATION, APPENDIX Jeanne Sun New <915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso Revision <1226> VERIFICATION OF COMPENDIAL PROCEDURES PF 44(3) Pg. ONLINE VERIFICATION REQUIREMENTS Horacio Pappa New <1671> THE DETERMINATION AND APPLICATION OF MOISTURE VAPOR TRANSMISSION RATE PF 44(3) Pg. ONLINE Introduction, INTRODUCTION, PACKAGING SYSTEMS, DESICCANT VERSUS WATER MVTR METHOD, EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION METHOD, REPACKAGING OF SODFS, GLOSSARY, REFERENCES Desmond Hunt
Transcript of Compendial Deferrals for USP42-NF37 1S · pharmaceutical compounding--nonsterile preparations pf...
Compendial Deferrals for USP42-NF37 1S
Category Monograph Title Monograph Section Scientific Liaison
Revision EXCIPIENTS (USP and NF), LISTED BY CATEGORY PF 42(2) Pg. ONLINE
{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF, {Flavors and Fragrance} Anise Oil, {Flavors and Fragrance} Star Anise Oil Hong Wang
Revision GENERAL NOTICES TO USP-NF PF 44(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson
Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE
Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Guanidine Hydrochloride, Gadobutrol, Rotigotine, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Neohesperidin Dihydrochalcone, Tetrabenazine, Anise Oil, Choline Fenofibrate, Nisoldipine, Star Anise Oil Sujatha Ramakrishna
New <64> PROBIOTIC TESTS PF 43(2) Pg. ONLINE
Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo
Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE
??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine and Insulin Lispro Diane McCarthy
New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE
Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Elena Curti
New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINEDEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa
Revision <671> CONTAINERS--PERFORMANCE TESTING PF 44(3) Pg. ONLINE
Introduction, INTRODUCTION, MOISTURE VAPOR TRANSMISSION FOR PLASTIC PACKAGING SYSTEMS, CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS, SPECTRAL TRANSMISSION Desmond Hunt
Revision <701> DISINTEGRATION PF 44(2) Pg. ONLINE APPARATUS William Brown
Revision<795> PHARMACEUTICAL COMPOUNDING--NONSTERILE PREPARATIONS PF 44(3) Pg. ONLINE
Introduction, INTRODUCTION, CATEGORIES OF COMPOUNDING, RESPONSIBILITIES OF THE COMPOUNDER, COMPOUNDING PROCESS, COMPOUNDING FACILITIES, COMPOUNDING EQUIPMENT, COMPONENT SELECTION, HANDLING, AND STORAGE, STABILITY CRITERIA AND BEYOND-USE DATING, PACKAGING AND DRUG PREPARATION CONTAINERS, COMPOUNDING DOCUMENTATION, QUALITY CONTROL, PATIENT COUNSELING, TRAINING, COMPOUNDING FOR ANIMAL PATIENTS, GLOSSARY, 1. INTRODUCTION AND SCOPE, 2. PERSONNEL QUALIFICATIONS-TRAINING, EVALUATION, AND REQUALIFICATION, 3. PERSONAL HYGIENE AND GARBING, 4. BUILDINGS AND FACILITIES, 5. CLEANING AND SANITIZING, 6. EQUIPMENT AND COMPONENTS, 7. SOPS AND MASTER FORMULATION AND COMPOUNDING RECORDS, 8. RELEASE TESTING, 9. LABELING, 10. ESTABLISHING BEYOND-USE DATES, 11. QUALITY ASSURANCE AND QUALITY CONTROL, 12. CNSP HANDLING, PACKAGING, STORAGE, AND TRANSPORT, 13. COMPLAINT HANDLING AND ADVERSE EVENT REPORTING, 14. DOCUMENTATION, APPENDIX Jeanne Sun
New<915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso
Revision <1226> VERIFICATION OF COMPENDIAL PROCEDURES PF 44(3) Pg. ONLINE VERIFICATION REQUIREMENTS Horacio Pappa
New<1671> THE DETERMINATION AND APPLICATION OF MOISTURE VAPOR TRANSMISSION RATE PF 44(3) Pg. ONLINE
Introduction, INTRODUCTION, PACKAGING SYSTEMS, DESICCANT VERSUS WATER MVTR METHOD, EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION METHOD, REPACKAGING OF SODFS, GLOSSARY, REFERENCES Desmond Hunt
New<1850> EVALUATION OF SCREENING TECHNOLOGIES FOR ASSESSING MEDICINE QUALITY PF 44(3) Pg. ONLINE
Title, Introduction, 1. INTRODUCTION, 2. APPLICATION OF THE TECHNOLOGY, 3. GENERAL INFORMATION ABOUT THE TECHNOLOGY, 4. PERFORMANCE EVALUATION, 5. FIELD EVALUATION, GLOSSARY, REFERENCES Daniel Bempong
New <1912> MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso
Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony
Revision ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PF 43(5) Pg. ONLINE
IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Codeine N-Oxide RS Wei Yang
New ALBUTEROL INHALATION AEROSOL PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Alcohol Content, PERFORMANCE TESTS/Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders-Performance Quality Tests <601>, C. Aerodynamic Size Distribution-Inhalation Aerosols, Sprays, and Powders, PERFORMANCE TESTS/Delivered-Dose Uniformity (Between Units), PERFORMANCE TESTS/Delivered-Dose Uniformity (Within Unit), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Sulfate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound D RS Ravi Ravichandran
Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck
Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck
Revision ALLOPURINOL COMPOUNDED ORAL SUSPENSION PF 44(2) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Oral Suspension in SyrSpend SF PH4, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Brian Serumaga
New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C17H18N4O·HCl, Chemical Info/330.82, Chemical Info/1H-Pyrido[4,3-b]indol-1-one, 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-, hydrochloride;, Chemical Info/2,3,4,5-Tetrahydro-5-methyl-2-[(5-methylimidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Related Compound A RS Andrea Carney
New ALOSETRON TABLETS PF 43(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Related Compound A RS Andrea Carney
Revision AMCINONIDE CREAM PF 44(3) Pg. ONLINE
IDENTIFICATION/Thin-Layer Chromatography, ASSAY/Procedure, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butylparaben RS Mary Koleck
Revision AMIODARONE HYDROCHLORIDE INJECTION PF 44(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Limit of Iodide, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Edith Chang
New AMIODARONE HYDROCHLORIDE TABLETS PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amiodarone Hydrochloride RS Edith Chang
New AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Besylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Olmesartan Medoxomil RS Edith Chang
Revision AMPICILLIN AND SULBACTAM FOR INJECTION PF 44(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ampicillin System Suitability Mixture RS Ramanujam Prasad
Revision ANISE OIL PF 44(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Refractive Index, ASSAY/Content of trans-Anethole, IMPURITIES/Limit of Phenols, SPECIFIC TESTS/Specific Gravity <841>, SPECIFIC TESTS/Congealing Temperature <651>, SPECIFIC TESTS/Optical Rotation, Angular Rotation <781A>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Galina Holloway
New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Water Determination <921>, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Annatto Seed Tocotrienols Extract RS Huy Dinh
Revision ASPIRIN PF 41(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Substances Insoluble in Sodium Carbonate TS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Clydewyn Anthony
Revision ATOMOXETINE CAPSULES PF 44(1) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Heather Joyce
New AZACITIDINE PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C8H12N4O5, Chemical Info/244.20, Chemical Info/1,3,5-Triazin-2(1H)-one, 4-amino-1-β-d-ribofuranosyl-;, Chemical Info/4-Amino-1-β-d-ribofuranosyl-s-triazin-2(1H)-one, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 1-β-d-Ribofuranosyl-3-guanylurea, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine Related Compound C RS Feiwen Mao
Revision AZATHIOPRINE TABLETS PF 43(3) Pg. ONLINE
IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azathioprine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mercaptopurine RS Feiwen Mao
Revision AZITHROMYCIN TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/B. Infrared Absorption <197A>, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP N-Demethylazithromycin RS Praveen Pabba
Omission BELLADONNA LEAF PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimOmission BELLADONNA EXTRACT PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimOmission BELLADONNA EXTRACT TABLETS PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimOmission BELLADONNA TINCTURE PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim
Revision BENZONATATE PF 44(1) Pg. ONLINE
Chemical Info/Chemical NameChemical Info/Chemical StructureChemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetracaine Related Compound B RS Wei Yang
Revision BENZTROPINE MESYLATE PF 44(3) Pg. ONLINE
Chemical Info/403.53403.54, (1R,3r,5S)-3-(Benzhydryloxy)-8-methyl-8-azabicyclo[3.2.1]octane methanesulfonate, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benztropine Related Compound A RS Heather Joyce
Revision BENZTROPINE MESYLATE INJECTION PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benztropine Related Compound A RS Heather Joyce
Revision BENZTROPINE MESYLATE TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benztropine Related Compound A RS Heather Joyce
Revision BETAMETHASONE DIPROPIONATE CREAM PF 42(6) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck
Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck
Revision BETAXOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betaxolol Related Compound A RS Feiwen Mao
Revision BETAXOLOL TABLETS PF 43(6) Pg. ONLINE
IDENTIFICATION/B, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betaxolol Related Compound A RS Feiwen Mao
New BITTER ORANGE FRUIT FLAVONOIDS DRY EXTRACT PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bitter Orange Fruit Flavonoids Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naringin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin RS Maria Monagas
New BIVALIRUDIN PF 44(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C98H138N24O33, Chemical Info/2180.29 (free base), Chemical Info/l-Leucine, d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-;, Chemical Info/d-Phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-l-leucine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Amino Acid Content, IDENTIFICATION/D. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure 1, ??UNKNOWN??/Procedure 2, OTHER COMPONENTS/Trifluoroacetic Acid (TFA) in Peptides <503.1>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [des-Glu13]-Bivalirudin RS Elena Curti
New BIVALIRUDIN FOR INJECTION PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS Elena Curti
Revision BROMOCRIPTINE MESYLATE CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck
New BUDESONIDE NASAL SPRAY PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Potassium Sorbate, OTHER COMPONENTS/Content of Edetate Disodium, PERFORMANCE TESTS/Delivered-Dose Uniformity, PERFORMANCE TESTS/Minimum Fill <755>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Edetate Disodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Potassium Sorbate RS Richard Nguyen
Revision BUMETANIDE PF 44(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang
Revision BUMETANIDE INJECTION PF 44(1) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bumetanide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang
Revision BUMETANIDE TABLETS PF 43(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bumetanide Related Compound B RS Edith Chang
Revision CAFFEINE CITRATE INJECTION PF 43(6) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Color and Clarity, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Theophylline RS Heather Joyce
New CALCIPOTRIENE TOPICAL SOLUTION PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Isopropyl Alcohol Content, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Calcipotriene RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Calcipotriene Related Compound C RS Feiwen Mao
Revision CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS PF 43(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Captopril Disulfide, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Captopril Disulfide RS Edith Chang
Revision CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS PF 44(1) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Heather Joyce
Revision LOW-SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Tong Liu
Revision CEFEPIME FOR INJECTION PF 44(2) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Procedure 2, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane
Revision CEFIXIME PF 44(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation Slavica Shane
New CEFIXIME CAPSULES PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cefixime RS Slavica Shane
Revision CEFIXIME FOR ORAL SUSPENSION PF 44(1) Pg. ONLINE
IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> Slavica Shane
Revision CEFIXIME TABLETS PF 44(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane
Revision CEFOTETAN FOR INJECTION PF 43(6) Pg. ONLINE
IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, Labels and Labeling for Injectable Products, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Slavica Shane
Revision CEFOTETAN DISODIUM PF 43(6) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Slavica Shane
Revision CELECOXIB PF 43(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Limit of Celecoxib Related Compound D, IMPURITIES/Limits of 4-Hydrazinylbenzenesulfonamide Hydrochloride and Sulfanilamide, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Hydrazinylbenzenesulfonamide Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilamide RS Wei Yang
New CELECOXIB CAPSULES PF 43(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound C RS Wei Yang
Revision CEPHALEXIN PF 43(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Procedure 2, ADDITIONAL REQUIREMENTS/Labeling Slavica Shane
Revision CEPHALEXIN CAPSULES PF 43(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Slavica Shane
Revision CEPHALEXIN FOR ORAL SUSPENSION PF 43(6) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica ShaneNew CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish Li
New CHINESE SKULLCAP ROOT PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavone Glucuronides and Flavone Aglycons, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein 7-O-Glucuronide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Scutellaria baicalensis Root Dry Extract RS Cuiying Ma
New CHINESE SKULLCAP ROOT DRY EXTRACT PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavone Glucuronides and Flavone Aglycons, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein 7-O-Glucuronide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Scutellaria baicalensis Root Dry Extract RS Cuiying Ma
New CHINESE SKULLCAP ROOT POWDER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavone Glucuronides and Flavone Aglycons, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein 7-O-Glucuronide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Scutellaria baicalensis Root Dry Extract RS Cuiying Ma
New CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran
Revision CHLOROTHIAZIDE SODIUM FOR INJECTION PF 44(2) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities Edith Chang
Revision CHLORZOXAZONE PF 43(4) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, OTHER COMPONENTS/Chlorine Content, IMPURITIES/Chromatographic Purity, IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Heather Joyce
Revision CHLORZOXAZONE TABLETS PF 43(4) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorzoxazone Related Compound A RS Heather Joyce
New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C22H28ClNO5, Chemical Info/421.91, Chemical Info/Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (1:1);, Chemical Info/2-Hydroxy-N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate Related Compound C RS Sujatha Ramakrishna
New CHRYSANTHEMUM FLOWER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia Coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Apigenin-7-glucoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
New CHRYSANTHEMUM FLOWER DRY EXTRACT PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia Coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Apigenin-7-glucoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
New CHRYSANTHEMUM FLOWER POWDER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia Coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Apigenin-7-glucoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
Revision CIPROFLOXACIN OPHTHALMIC OINTMENT PF 44(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Shankari Shivaprasad
Revision CIPROFLOXACIN OPHTHALMIC SOLUTION PF 44(3) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Shankari Shivaprasad
New CLIMBAZOLE PF 43(4) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C15H17ClN2O2, Chemical Info/292.76, Chemical Info/1-(p-Chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2-butanone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Climbazole RS Sujatha Ramakrishna
Revision CLINDAMYCIN INJECTION PF 44(2) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad
Revision CLINDAMYCIN HYDROCHLORIDE CAPSULES PF 44(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage Ramanujam Prasad
Revision CLINDAMYCIN PHOSPHATE PF 44(3) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Ramanujam Prasad
Revision CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION PF 44(2) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad
Revision CLINDAMYCIN PHOSPHATE VAGINAL INSERTS PF 44(2) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad
Revision CLOBETASOL PROPIONATE OINTMENT PF 44(2) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Beclomethasone Dipropionate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clobetasol Propionate Related Compound A RS Mary Koleck
Revision CLOMIPHENE CITRATE TABLETS PF 43(4) Pg. ONLINE
IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck
Revision CLONAZEPAM PF 44(3) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Clonazepam Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clonazepam Related Compound C RS Heather Joyce
Revision CLONAZEPAM TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/Infrared Absorption, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Heather Joyce
New CREATINE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C4H9N3O2·H2O, Chemical Info/149.15, Chemical Info/Glycine, N-(aminoiminomethyl)-N-methyl-, monohydrate;, Chemical Info/N-Carbamimidoyl-N-methylglycine monohydrate, Chemical Info/CAS, Chemical Info/C4H9N3O2, Chemical Info/131.14, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Chloride and Sulfate <221>, Sulfate, ??UNKNOWN??/Note, ??UNKNOWN??/Procedure 1, ??UNKNOWN??/Procedure 2, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Creatine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Creatinine RS Huy Dinh
Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck
Revision DACARBAZINE PF 44(2) Pg. ONLINE
Chemical Info/1H-Imidazole-4-carboxamide, 5-(3,3-dimethyl-1-triazenyl)-;1H-Imidazole-4-carboxamide, 5-(3,3-dimethyltriaz-1-enyl)-;, Chemical Info/5-(3,3-Dimethyl-1-triazeno)imidazole-4-carboxamide5-(3,3-Dimethyltriaz-1-enyl)-1H-imidazole-4-carboxamide, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Dimethylamine, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ 5-Aminoimidazole-4-carboxamide hydrochloride.C4H6N4O·HCl 162.58, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dimethylamine Solution RS Feiwen Mao
Revision DACARBAZINE FOR INJECTION PF 44(2) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of 2-Azahypoxanthine, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ Feiwen Mao
New DEFERASIROX PF 43(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C21H15N3O4, Chemical Info/373.36, Chemical Info/Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-;, Chemical Info/4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Deferasirox RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Deferasirox System Suitability Mixture RS Andrea Carney
Revision DESOXIMETASONE PF 44(2) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>or <197A>, IDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desoximetasone Related Compound A RS Mary Koleck
New DESVENLAFAXINE EXTENDED-RELEASE TABLETS PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY, ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Venlafaxine Hydrochloride RS Heather Joyce
Revision DEXAMETHASONE ELIXIR PF 43(6) Pg. ONLINE
IDENTIFICATION/Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS Mary Koleck
Revision DEXAMETHASONE ORAL SOLUTION PF 43(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylparaben RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propylparaben RS Mary Koleck
Revision DEXAMETHASONE SODIUM PHOSPHATE INJECTION PF 43(3) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Sodium Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Mary Koleck
Revision DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Sodium Phosphate RS Mary Koleck
Revision DEXTROMETHORPHAN PF 43(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N-Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony
Revision DEXTROMETHORPHAN HYDROBROMIDE PF 43(5) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N-Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony
New DICLOFENAC POTASSIUM FOR ORAL SOLUTION PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Potassium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Related Compound A RS Wei Yang
New DICLOFENAC SODIUM TOPICAL GEL PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Related Compound A RS Wei Yang
Revision DICYCLOMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Readily Carbonizable Substances Test <271>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
Revision DICYCLOMINE HYDROCHLORIDE CAPSULES PF 43(6) Pg. ONLINE
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
Revision DICYCLOMINE HYDROCHLORIDE INJECTION PF 43(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Behnaz Almasi
Revision DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION PF 43(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
Revision DICYCLOMINE HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
Omission DIGITALIS PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimOmission POWDERED DIGITALIS PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimOmission DIGITALIS CAPSULES PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim
Omission DIGITALIS TABLETS PF 44(3) Pg. ONLINE Entire document Nam-Cheol KimRevision DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Clydewyn Anthony
Revision DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION PF 43(5) Pg. ONLINE
IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony
New DIPHENHYDRAMINE HYDROCHLORIDE TABLETS PF 43(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a Pooled Sample, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony
RevisionDIPHENHYDRAMINE AND PHENYLEPHRINE HYDROCHLORIDES TABLETS PF 43(5) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Clydewyn Anthony
New DIPHENHYDRAMINE HYDROCHLORIDE ORAL POWDER PF 43(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony
Revision DISULFIRAM PF 43(6) Pg. ONLINE
Chemical Info/296.54296.52, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/<291>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741> Heather Joyce
Revision DOBUTAMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dobutamine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dopamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Raspberry Ketone RS Edith Chang
New DONG QUAI ROOT PF 43(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma
New DONG QUAI ROOT POWDER PF 43(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma
Revision DOXYCYCLINE PF 44(2) Pg. ONLINE
Chemical Info/ (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Related Compound A RS Praveen Pabba
Revision DOXYCYCLINE HYCLATE PF 44(2) Pg. ONLINE
Chemical Info/Chemical Structure, Chemical Info/ (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Related Compound A RS Praveen Pabba
New ELETRIPTAN HYDROBROMIDE PF 43(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C22H26N2O2S·HBr, Chemical Info/463.43, Chemical Info/C22H26N2O2S·HBr·H2O, Chemical Info/481.45, Chemical Info/(R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide;, Chemical Info/3-{[(R)-1-Methyl-2-pyrrolidinyl]methyl}-5-[2-(phenylsulfonyl)ethyl]indole, monohydrobromide, Chemical Info/CAS, Chemical Info/Monohydrate, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Bromide, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Eletriptan S-Enantiomer, IMPURITIES/Limit of Isopropyl p-Toluenesulfonate (if present), IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan S-Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl p-Toluenesulfonate RS Heather Joyce
Revision EPHEDRINE PF 43(5) Pg. ONLINE
IDENTIFICATION/A.Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony
Revision EPHEDRINE SULFATE PF 43(5) Pg. ONLINE
Chemical Info/Chemical Structure, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony
Revision EPINEPHRINE PF 42(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna
New EPOPROSTENOL SODIUM PF 44(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C20H31NaO5, Chemical Info/374.45, Chemical Info/Prosta-5,13-dien-1-oic acid, 6,9-epoxy-11,15-dihydroxy-, sodium salt, (5Z,9α,11α,13E,15S)-;, Chemical Info/Sodium (Z)-(3aR,4R,5R,6aS)-hexahydro-5-hydroxy-4-[(E)-(3S)-3-hydroxy-1-octenyl]-2H-cyclopenta[b]furan-Δ2-valerate;, Chemical Info/Sodium (Z)-5-{(3aR,4R,5R,6aS)-5-hydroxy-4-[(S,E)-3-hydroxyoct-1-en-1-yl]hexahydro-2H-cyclopenta[b]furan-2-ylidene}pentanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Hydroxide, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol Sodium System Suitability Mixture RS Gerald Hsu
New EPOPROSTENOL FOR INJECTION PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol Related Compound A RS Gerald Hsu
New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the γ-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/≊50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (γ-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, ASSAY/Concentration of Eptacog Alfa Activated, IMPURITIES/Gla-Domainless Eptacog Alfa Activated (γ-Carboxylation) Kevin Carrick
New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Content of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, SPECIFIC TESTS/Water Determination <921>, Method 1c, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Constituted Solution, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements <659>, Injection Packaging, Sterile solids packaging, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, ASSAY/Content of Eptacog Alfa Activated Kevin Carrick
Omission ERGOLOID MESYLATES SUBLINGUAL TABLETS PF 44(2) Pg. ONLINE Entire document Heather JoyceOmission ERGOTAMINE TARTRATE SUBLINGUAL TABLETS PF 44(2) Pg. ONLINE Entire document Heather Joyce
Revision ESCITALOPRAM ORAL SOLUTION PF 44(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Citalopram Related Compound B, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citalopram Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citalopram Related Compound C RS Heather Joyce
Omission ETHOTOIN PF 43(3) Pg. ONLINE Entire document Heather JoyceOmission ETHOTOIN TABLETS PF 43(3) Pg. ONLINE Entire document Heather Joyce
New EVEROLIMUS PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C53H83NO14, Chemical Info/958.22, Chemical Info/(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone;, Chemical Info/(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Alcohol, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Sirolimus, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Organisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sirolimus RS Morgan Puderbaugh
New FENOFIBRIC ACID DELAYED-RELEASE CAPSULES PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS Sujatha Ramakrishna
Revision FENTANYL PF 44(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fentanyl Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fentanyl Related Compound G RS Wei Yang
New FEXOFENADINE HYDROCHLORIDE ORAL SUSPENSION PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propylparaben RS Gerald Hsu
Revision FLUCONAZOLE TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound C RS Shankari Shivaprasad
Revision FLUOXETINE HYDROCHLORIDE PF 43(6) Pg. ONLINE IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities Heather JoyceRevision FOSFOMYCIN TROMETHAMINE PF 44(2) Pg. ONLINE IMPURITIES/Organic Impurities Shankari Shivaprasad
New GADOBUTROL PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C18H31GdN4O9·H20, Chemical Info/622.73, Chemical Info/Gadolinium, [10-[2-(hydroxy-&kgr;O)-3-hydroxy-1-(hydroxymethyl)propyl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)-&kgr;N1, &kgr;N4, &kgr;N7, &kgr;N10,&kgr;O1, &kgr;O4, &kgr;O7]-, monohyrdate, [SA-8-1425362′5′-(R*,S*)]-;, Chemical Info/ [10-[(2RS,3SR)-1,2,3-Trihydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)]gadolinium monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, Chemical Info/604.71, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Gadobutrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Gadobutrol System Suitability Mixture RS Ravi Ravichandran
New GADOTERATE MEGLUMINE INJECTION PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C16H25GdN4O8·C7H17NO5, Chemical Info/753.86, Chemical Info/d-Glucitol, 1-deoxy-1-(methylamino)-, [1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-&kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate(1-) (1:1);, Chemical Info/1-Deoxy-1-(methylamino)-d-glucitol hydrogen [1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-&kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate(1-), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Meglumine, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Limit of Free Tetraxetan, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Container Content for Injections <697>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gadoterate Meglumine RS Ravi Ravichandran
Revision GALANTAMINE ORAL SOLUTION PF 44(3) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Mixture RS Heather Joyce
Revision GALANTAMINE EXTENDED-RELEASE CAPSULES PF 44(3) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Mixture RS Heather Joyce
Revision GALANTAMINE TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Mixture RS Heather Joyce
Revision GALANTAMINE HYDROBROMIDE PF 44(3) Pg. ONLINE
Chemical Info/Chemical Name (4aS,6R,8aS)-3-Methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide; (4aS,6R,8aS)-3-Methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol hydrobromide, IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Bromide, ASSAY/Procedure, IMPURITIES/Limit of Palladium, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation <781><781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Racemic RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Mixture RS Heather Joyce
Revision GENTAMICIN SULFATE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., IMPURITIES/Organic Impurities, SPECIFIC TESTS/Content of Gentamicins Slavica Shane
Revision GLUCAGON PF 44(3) Pg. ONLINEDEFINITION/Introduction, IDENTIFICATION/B., SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling Elena Curti
Revision GONADORELIN ACETATE PF 44(2) Pg. ONLINE
Chemical Info/1374.461182.3 (acetic acid free, anhydrous), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Acetic Acid in Peptides <503>, ??UNKNOWN??/Gonadorelin-Related Impurities, Procedure 1, ??UNKNOWN??/Gonadorelin-Related Impurities, Procedure 2, ??UNKNOWN??/Acetic Acid and Trifluoroacetic Acid, ??UNKNOWN??/Limit of Fluoride, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Amino Acid Analysis, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [D-His2]-Gonadorelin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [D-Tyr5]-Gonadorelin RS Michael Huang
New GUANIDINE HYDROCHLORIDE PF 43(4) Pg. ONLINE
IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, Title, Chemical Info/Chemical Structure, Chemical Info/CH5N3·HCl, Chemical Info/95.53, Chemical Info/Guanidine, hydrochloride (1:1);, Chemical Info/Guanidine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Limit of Nitrate, IMPURITIES/Limit of Cyanide, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Acidity, SPECIFIC TESTS/Water-Insoluble Substances, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class 1, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guanidine Hydrochloride RS Galina Holloway
New GUARANA SEED PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeine and Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas
New GUARANA SEED DRY EXTRACT PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC for Flavonoids, COMPOSITION/Content of Caffeine, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas
New GUARANA SEED POWDER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeine and Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas
Revision HISTIDINE PF 43(6) Pg. ONLINE
IDENTIFICATION/B., IMPURITIES/Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Alanine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Arginine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Lysine Hydrochloride RS Fatkhulla Tadjimukhamedov
Revision HYDROCORTISONE ACETATE PF 44(3) Pg. ONLINE
IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cortisone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone Acetate RS Gerald Hsu
Revision HYDROCORTISONE ACETATE CREAM PF 44(3) Pg. ONLINE
IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cortisone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone Acetate RS Gerald Hsu
Revision HYDROXYCHLOROQUINE SULFATE PF 44(2) Pg. ONLINE
IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/B. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities Shankari Shivaprasad
Revision HYDROXYCHLOROQUINE SULFATE TABLETS PF 44(3) Pg. ONLINE ASSAY/Procedure, PERFORMANCE TESTS/Organic Impurities Shankari Shivaprasad
Revision IFOSFAMIDE PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 2-Chloroethylamine Hydrochloride, IMPURITIES/Chloroform-Insoluble Phosphorus, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Monoethanolamine RS Feiwen Mao
Revision IFOSFAMIDE FOR INJECTION PF 43(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Monoethanolamine RS Feiwen Mao
New IFOSFAMIDE INJECTION PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ifosfamide Related Compound C, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/ pH <791>, SPECIFIC TESTS/Color and Light Transmission, SPECIFIC TESTS/Osmolality and Osmolarity <785>, Osmolality, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound C RS Feiwen Mao
New ISCOTRIZINOL PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C44H59N7O5, Chemical Info/765.98, Chemical Info/Benzoic acid, 4,4′-[[6-[[4-[[(1,1-dimethylethyl)amino]carbonyl]phenyl]amino]-1,3,5-triazine-2,4-diyl]diimino]bis-, bis(2-ethylhexyl) ester;, Chemical Info/Bis(2-ethylhexyl) 4,4′-[(6-{[4-(tert-butylcarbamoyl)phenyl]amino}-1,3,5-triazine-2,4-diyl)diimino]dibenzoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound I RS Feiwen Mao
New L-ALPHA-GLYCERYLPHOSPHORYLCHOLINE PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C8H20NO6P, Chemical Info/257.22, Chemical Info/Choline hydroxide, (R)-2,3-dihydroxypropyl hydrogen phosphate, inner salt;, Chemical Info/(R)-2,3-Dihydroxypropyl 2-(trimethylammonio)ethyl phosphate;, Chemical Info/l-α-Glycerylphosphorylcholine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Chloride, Sulfate, Phosphate, and Acetate, IMPURITIES/Limit of Glycerol, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <2021>, SPECIFIC TESTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species, Test for Absence of Escherichia coli, and Test for Absence of Staphylococcus aureus, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerophosphorylethanolamine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerylphosphorylcholine Solution RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP beta-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Serine RS Huy Dinh
New L113 PF 43(4) Pg. ONLINE L113- Michael ChangNew L115 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish LiNew L116 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li
New LACOSAMIDE PF 43(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C13H18N2O3, Chemical Info/250.30, Chemical Info/Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-;, Chemical Info/(+)-(2R)-2-(Acetylamino)-N-benzyl-3-methoxypropanamide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Lacosamide S-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide S-Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound B RS Ren-Hwa Yeh
New LACOSAMIDE INJECTION PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound F RS Ren-Hwa Yeh
New LACOSAMIDE ORAL SOLUTION PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound F RS Ren-Hwa Yeh
New LACOSAMIDE TABLETS PF 43(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound F RS Ren-Hwa Yeh
New LACTULOSE PF 43(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C12H22O11, Chemical Info/342.30, Chemical Info/d-Fructose, 4-O-β-d-galactopyranosyl-;, Chemical Info/4-O-β-d-Galactopyranosyl-d-fructofuranose, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epilactose RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactose Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactulose RS Andrea Carney
Revision LIDOCAINE OINTMENT PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen
Revision LIDOCAINE HYDROCHLORIDE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197>, ASSAY/Procedure, IMPURITIES/Organic Impurities Richard Nguyen
Revision LIDOCAINE HYDROCHLORIDE JELLY PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen
New CONJUGATED LINOLEIC ACIDS-TRIGLYCERIDES PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., COMPOSITION/Content of Conjugated Linoleic Acids-Tri-, Di-, Monoglycerides and Polymerized Triglycerides, IMPURITIES/Limit of Benzo[a]pyrene, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Fatty Acid Composition, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Conjugated Linoleic Acids-Triglycerides RS Huy Dinh
Revision LIOTHYRONINE SODIUM PF 43(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure, IMPURITIES/Chloride Content, SPECIFIC TESTS/Sodium Content, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levothyroxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Liothyronine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Liothyronine Sodium RS Andrea Carney
Revision LOPERAMIDE HYDROCHLORIDE PF 43(4) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Loperamide System Suitability Mixture RS Andrea Carney
Revision MILK OF MAGNESIA PF 44(3) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM CARBONATE PF 44(2) Pg. ONLINE
IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Carbonate, ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM HYDROXIDE PF 44(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Soluble Salts, IMPURITIES/Limit of Calcium, IMPURITIES/Limit of Lead, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM HYDROXIDE PASTE PF 44(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, IMPURITIES/Limit of Lead, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM OXIDE PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM OXIDE CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM OXIDE TABLETS PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM TRISILICATE PF 44(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Content of Magnesium Oxide, IMPURITIES/Soluble Salts, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Omission MANGANESE CHLORIDE FOR ORAL SOLUTION PF 44(2) Pg. ONLINE Entire document Gerald Hsu
Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu
New MESNA INJECTION PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzaldehyde RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound B RS Hillary Cai
Omission METAPROTERENOL SULFATE INHALATION SOLUTION PF 44(2) Pg. ONLINE Entire document Ravi Ravichandran
Revision METARAMINOL BITARTRATE PF 44(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Metaraminol Related Compound B, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Content of Tartaric Acid, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Enantiomer RS Donald Min
Omission METHYLCELLULOSE OPHTHALMIC SOLUTION PF 44(3) Pg. ONLINE Entire document Feiwen MaoOmission METHYLCELLULOSE ORAL SOLUTION PF 44(3) Pg. ONLINE Entire document Feiwen Mao
Revision METHYLPREDNISOLONE PF 44(3) Pg. ONLINE
IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound H RS Gerald Hsu
Revision METHYLPREDNISOLONE HEMISUCCINATE PF 44(3) Pg. ONLINE
IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Hemisuccinate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Hemisuccinate Related Compound D RS Gerald Hsu
Omission METHYSERGIDE MALEATE PF 44(3) Pg. ONLINE Entire document Mary Koleck
Revision MICONAZOLE PF 41(5) Pg. ONLINEADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound C RS Clydewyn Anthony
New MILNACIPRAN HYDROCHLORIDE PF 43(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C15H22N2O·HCl, Chemical Info/282.81, Chemical Info/Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, monohydrochloride, (1R,2S)-rel-;, Chemical Info/(1RS,2SR)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride;, Chemical Info/Z-2 Aminomethyl-1-phenyl-N,N-diethylcyclopropanecarboxamide hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Early Eluting Organic Impurities, IMPURITIES/Late Eluting Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound C RS (1RS,2SR)-2-[(1,3-Dioxoisoindolin-2-yl)methyl]-N,N-diethyl-1-phenylcyclopropane-1-carboxamide.C23H24N2O3376.46 Mary Koleck
New MILNACIPRAN HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound A RS (1RS,2SR)-2-(Aminomethyl)-1-phenylcyclopropane-1-carboxylic acid hydrochloride.C11H13NO2·HCl227.69, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound B RS (1RS,5SR)-1-Phenyl-3-azabicyclo[3.1.0]hexan-2-one.C11H11NO173.21 Mary Koleck
Omission MINOCYCLINE HYDROCHLORIDE ORAL SUSPENSION PF 44(3) Pg. ONLINE Entire document Praveen Pabba
Revision MINOXIDIL PF 44(2) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Donald Min
Revision MINOXIDIL TABLETS PF 44(2) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min
Revision NABUMETONE TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nabumetone Related Compound A RS Hillary Cai
Revision NAPROXEN PF 42(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms, Method B Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
New NEOHESPERIDIN DIHYDROCHALCONE PF 43(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C28H36O15, Chemical Info/ 612.58, Chemical Info/1-Propanone, 1-[4-[[2-O-(6-deoxy-α-l-mannopyranosyl)-β-d-glucopyranosyl]oxy]-2, 6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)-;, Chemical Info/3,5-Dihydroxy-4-[3-(3-hydroxy-4-methoxyphenyl)propanoyl]phenyl 2-O-(α-l-rhamnopyranosyl)-β-d-glucopyranoside, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neodiosmin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin Dihydrochalcone RS Peng Zhang
New NILOTINIB PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C28H22F3N7O·HCl·H2O, Chemical Info/584.00, Chemical Info/Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino, monohydrochloride, monohydrate;, Chemical Info/4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}benzamide hydrochloride monohydrate, Chemical Info/CAS, Chemical Info/C28H22F3N7O, Chemical Info/529.52, Chemical Info/Free base, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Nilotinib Related Compound A, Nilotinib Related Compound B, and Nilotinib Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib System Suitability Mixture RS Feiwen Mao
Revision NISOLDIPINE PF 43(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C20H24N2O6, Chemical Info/388.41, Chemical Info/3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (±)-;, Chemical Info/(±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nifedipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound G RS Donald Min
Revision DILUTED NITROGLYCERIN PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2-Mononitroglycerin RS Donald Min
Revision NITROGLYCERIN INJECTION PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2-Mononitroglycerin RS Donald Min
Revision NITROGLYCERIN OINTMENT PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2-Mononitroglycerin RS Donald Min
Revision NITROGLYCERIN SUBLINGUAL TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2-Mononitroglycerin RS Donald Min
Omission NITROMERSOL PF 44(3) Pg. ONLINE Entire document Shankari Shivaprasad
Revision NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS PF 43(6) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethinyl Estradiol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh
Revision NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS PF 44(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1: Norethindrone Acetate Related Compounds, IMPURITIES/Organic Impurities, Procedure 2: Ethinyl Estradiol Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estrone RS Ren-Hwa Yeh
Revision NORGESTREL PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature<741>, Class I, SPECIFIC TESTS/Limit of Ethynyl Group, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norgestrel Related Compound L RS Ren-Hwa Yeh
Omission NORGESTREL TABLETS PF 44(3) Pg. ONLINE Entire document Ren-Hwa Yeh
New OMEGA-3 FREE FATTY ACIDS PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., COMPOSITION/Content of EPA, DHA, and Total Omega-3 Free Fatty Acids, IMPURITIES/Cholesterol, IMPURITIES/Oligomers, IMPURITIES/Limit of Dioxins, Furans, and Polychlorinated Biphenyls (PCBs), IMPURITIES/Limit of Total Unidentified Fatty Acid Methyl Esters, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Anisidine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Ester Value, SPECIFIC TESTS/Absorbance, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cholesterol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Docosahexaenoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eicosapentaenoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Tricosanoate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omega-3 Free Fatty Acids RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alpha Tocopherol RS Huy Dinh
NewOMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, IDENTIFICATION/D. Identification Tests-General <191>, Chemical Identification Tests, Bicarbonate, ASSAY/Procedure for Omeprazole, ASSAY/Procedure for Sodium Bicarbonate, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Acid-Neutralizing Capacity <301>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound F and G Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound I RS Richard Nguyen
Revision ORLISTAT CAPSULES PF 43(5) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Orlistat Related Compound D RS Hillary Cai
Revision OXAPROZIN PF 44(2) Pg. ONLINE IDENTIFICATION/, IMPURITIES/Organic Impurities Hillary Cai
Revision OXAZEPAM CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Gerald Hsu
Revision PAMABROM PF 43(2) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/8-Bromotheophylline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pamabrom Related Compound A RS Clydewyn Anthony
Revision PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINE
IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound G RS Clydewyn Anthony
New 0.2% PHOSPHORIC ACID TS PF 44(3) Pg. ONLINE 0.2% Phosphoric Acid TS- Sridevi Ramachandran
New POLIDOCANOL PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C30H62O10, Chemical Info/ n = an average of nine (9), Chemical Info/582.8 (based on an average of 9 moieties), Chemical Info/Poly(oxy-1,2-ethanediyl), α-dodecyl-ω-hydroxy-;, Chemical Info/Polyethylene glycol monododecyl ether (average polymer, n = 9; nonaethylene glycol monododecyl ether), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, ASSAY/Distribution of Oligomers, ASSAY/Average Oligomer Chain Length, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ethylene Oxide and 1,4-Dioxane, IMPURITIES/Limit of Formaldehyde and Acetaldehyde, IMPURITIES/Limit of Formic Acid and Acetic Acid, SPECIFIC TESTS/Alkalinity, SPECIFIC TESTS/Appearance of Solution, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Saponification Value, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Polidocanol RS Donald Min
Revision POTASSIUM SORBATE PF 44(2) Pg. ONLINE
2,4-Hexadienoic acid, potassium salt;, Chemical Info/Chemical Name Potassium (2E,4E)-hexa-2,4-dienoate;, Chemical Info/Chemical Name, DEFINITION/Introduction, IDENTIFICATION/B.Infrared Absorption <197A> or <197K>, ASSAY/Procedure, ASSAY/Procedure 1: Content of Potassium Sorbate, ASSAY/Procedure 2: Content of Potassium, IMPURITIES/Limit of Aldehyde, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Peng Zhang
New PRAMIPEXOLE DIHYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Dihydrochloride Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Related Compound G RS Ravi Ravichandran
Revision PRAZOSIN HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prazosin Hydrochloride RS Donald Min
Revision PRIMIDONE TABLETS PF 44(1) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Claire Chisolm
Revision PROGESTERONE PF 43(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> <197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ Ren-Hwa Yeh
Revision PROGESTERONE INJECTION PF 43(6) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone System Suitability Mixture RS Ren-Hwa Yeh
Revision PROPRANOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class Ia <741>, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Propranolol Related Compound A RS Donald Min
Revision PROPRANOLOL HYDROCHLORIDE INJECTION PF 44(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propranolol Related Compound A RS Donald Min
Revision PROPRANOLOL HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Propranolol Related Compound A RS Donald Min
Revision PYRIDOSTIGMINE BROMIDE ORAL SOLUTION PF 44(2) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm
New PYRIDOSTIGMINE BROMIDE EXTENDED-RELEASE TABLETS PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Bromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm
New RANOLAZINE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C24H33N3O4, Chemical Info/427.55, Chemical Info/1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-,(±)-;, Chemical Info/N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-piperazin-1-ylacetamide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ranolazine Related Compound A, IMPURITIES/Limit of Epichlorohydrin, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound D RS Donald Min
New RANOLAZINE EXTENDED-RELEASE TABLETS PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound C RS Donald Min
Revision ROPINIROLE TABLETS PF 44(2) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Claire Chisolm
New ROPIVACAINE PF 43(1) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C17H26N2O, Chemical Info/274.40, Chemical Info/(S)-(-)-1-Propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide;, Chemical Info/(S)-(-)-1-Propyl-2′,6′-pipecoloxylidide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Color, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound B RS Ren-Hwa Yeh
New ROTIGOTINE PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C19H25NOS, Chemical Info/315.47, Chemical Info/1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl [2-(2-thienyl)ethyl]amino-(6S)-;, Chemical Info/(-)-(S)-5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthol;, Chemical Info/(6S)-6-[Propyl(2-(2-thienyl)ethyl)amino]-5,6,7,8-tetrahydro-1-naphthalenol, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Rotigotine R-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Racemate RS Ravi Ravichandran
New ROTIGOTINE TRANSDERMAL SYSTEM PF 43(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Drug Release <724>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound K RS Ravi Ravichandran
Revision SACCHARIN PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/⧫, SPECIFIC TESTS/⧫, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, ADDITIONAL REQUIREMENTS/⧫ Tong Liu
Revision SACCHARIN CALCIUM PF 44(2) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP o-Toluenesulfonamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Toluenesulfonamide RS Tong Liu
Revision SACCHARIN SODIUM PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/⧫, ASSAY/Procedure, IMPURITIES/⧫, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/⧫, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP o-Toluenesulfonamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Toluenesulfonamide RS Tong Liu
Revision SALICYLIC ACID GEL PF 44(1) Pg. ONLINE
IDENTIFICATION/A. Procedure, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Clydewyn Anthony
Revision SALICYLIC ACID PLASTER PF 43(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS Clydewyn Anthony
Revision SELENIUM SULFIDE TOPICAL SUSPENSION PF 43(3) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision SERTRALINE HYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Claire Chisolm
New SICHUAN LOVAGE RHIZOME PF 43(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS Cuiying Ma
New SICHUAN LOVAGE RHIZOME POWDER PF 43(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS Cuiying Ma
NewSITAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure 1: Sitagliptin, ASSAY/Procedure 2: Metformin Hydrochloride, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities: Sitagliptin, IMPURITIES/Organic Impurities: Metformin Hydrochloride, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metformin Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sitagliptin Phosphate RS Andrea Carney
New SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure 1: Sitagliptin, ASSAY/Procedure 2: Metformin Hydrochloride, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities: Sitagliptin, IMPURITIES/Organic Impurities: Metformin Hydrochloride, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metformin Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sitagliptin Phosphate RS Andrea Carney
Revision SODIUM LAUROYL SARCOSINATE PF 43(4) Pg. ONLINE
IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Laurate, IMPURITIES/Limit of Sodium Sulfate, Chemical Info/Chemical Structure, Chemical Info/Glycine, N-methyl-N-(1-oxododecyl)-, sodium salt;, Chemical Info/Sodium N-dodecanoyl-N-methylglycinate;, Chemical Info/Sodium N-lauroyl-N-methylglycinate;, Chemical Info/Sodium [dodecanoyl(methyl)amino]acetate, Chemical Info/C15H28NNaO3, Chemical Info/293.38, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B. Chromatographic Identity, IDENTIFICATION/C. Presence of Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Decanoyl Sarcosinate and Sodium Myristoyl Sarcosinate, IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Chloride, SPECIFIC TESTS/Acidity and Alkalinity, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Decanoyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Lauroyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Myristoyl Sarcosinate RS Hong Wang
Revision SODIUM MONOFLUOROPHOSPHATE PF 43(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Fluoride Ion, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Monofluorophosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfate RS Michael Chang
New SODIUM PHENYLBUTYRATE ORAL POWDER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Phenylbutyrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound B RS Behnaz Almasi
New SODIUM PHENYLBUTYRATE TABLETS PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Phenylbutyrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound B RS Behnaz Almasi
Revision SODIUM THIOSULFATE INJECTION PF 43(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Procedure, ASSAY/Procedure, IMPURITIES/Limit of Sulfate and Sulfite, IMPURITIES/Limit of Sulfide, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfate Anhydrous RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Thiosulfate RS Donald Min
New SORAFENIB TOSYLATE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C21H16ClF3N4O3·C7H8O3S, Chemical Info/637.03, Chemical Info/2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-, mono(4-methylbenzenesulfonate);, Chemical Info/4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide mono(4-methylbenzenesulfonate), Chemical Info/CAS, Chemical Info/Sorafenib (free base), Chemical Info/C21H16ClF3N4O3, Chemical Info/464.83, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Tosylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Related Compound H RS Feiwen Mao
Revision SORBIC ACID PF 44(2) Pg. ONLINE
Chemical Info/2,4-Hexadienoic acid, (E,E)-; 2,4-Hexadienoic acid;(2E,4E)-Hexa-2,4-dienoic acid;, Chemical Info/(E,E)-Sorbic acid Sorbic acid, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or<197K>, ASSAY/Procedure, IMPURITIES/Limit of Aldehyde Peng Zhang
Revision SPIRONOLACTONE TABLETS PF 44(2) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound B RS Donald Min
New TACROLIMUS OINTMENT PF 43(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Minimum Fill <755>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tacrolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tacrolimus Related Compound A RS Praveen Pabba
Revision TERBUTALINE SULFATE PF 44(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>or <197A>, IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sulfate, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound D RS Ren-Hwa Yeh
Revision TERBUTALINE SULFATE INJECTION PF 44(1) Pg. ONLINE
IDENTIFICATION/A. Thin Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A RS Ren-Hwa Yeh
Revision TERBUTALINE SULFATE TABLETS PF 44(1) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a pooled sample, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A RS Ren-Hwa Yeh
Revision TESTOSTERONE CYPIONATE INJECTION PF 44(2) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Cypionate Related Compound B RS Ren-Hwa Yeh
Revision TESTOSTERONE ENANTHATE PF 43(3) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, IMPURITIES/Free Heptanoic Acid, IMPURITIES/Limit of Heptanoic Acid and Testosterone Enanthate Related Compound H, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enanthic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound H RS Ren-Hwa Yeh
Revision TESTOSTERONE ENANTHATE INJECTION PF 43(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Heptanoic Acid, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enanthic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound G RS Ren-Hwa Yeh
New TETRABENAZINE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C19H27NO3, Chemical Info/317.42, Chemical Info/2-H-Benzo[a]quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-;, Chemical Info/(3RS,11bRS)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine Related Compound C RS Sridevi Ramachandran
Revision TETRACYCLINE HYDROCHLORIDE PF 43(3) Pg. ONLINEIDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731> Praveen Pabba
New TETRAXETAN PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C16H28N4O8, Chemical Info/404.42, Chemical Info/1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetraacetic acid;, Chemical Info/2,2′,2′′,2′′′-(1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetryl)tetraacetic acid., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan Related Compound A RS Ravi Ravichandran
Revision TRIAMCINOLONE ACETONIDE PF 43(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxymesterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound C RS Ren-Hwa Yeh
Revision TRIAMCINOLONE ACETONIDE LOTION PF 44(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound C RS Ren-Hwa Yeh
Revision TRIAMCINOLONE ACETONIDE OINTMENT PF 43(5) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS Ren-Hwa Yeh
Revision TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION PF 44(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound C RS Ren-Hwa Yeh
New TRIPTORELIN PAMOATE PF 43(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C64H82N18O13 · C23H16O6, Chemical Info/1311.45 (free base), Chemical Info/6-d-Tryptophan-, 4,4′-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (salt);, Chemical Info/ 5-Oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolylglycine amide, 4,4\'-methylenebis[3-hydroxy-2-naphthoate] (salt)., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Amino Acid Analysis, IDENTIFICATION/C. HPLC, ASSAY/Procedure, OTHER COMPONENTS/Pamoic Acid Content, ??UNKNOWN??/Triptorelin-Related Impurities, ??UNKNOWN??/Acetic Acid, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pamoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound C RS Dale Schmidt
Revision TRYPSIN PF 43(6) Pg. ONLINE
{Title}, Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Limit of Chymotrypsin, SPECIFIC TESTS/Solubility Test, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Crystallized RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Bovine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Recombinant Porcine RS Elena Curti
New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang
New VANCOMYCIN HYDROCHLORIDE COMPOUNDED ORAL SOLUTION PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Vancomycin B RS Jeanne Sun
Revision MICROCRYSTALLINE WAX PF 43(2) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Melting Range or Temperature <741>,Procedures, Procedure for Class III, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Melting Range or Temperature, Class III <741>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang
New WILD CHRYSANTHEMUM FLOWER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum indicum Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linarin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
New WILD CHRYSANTHEMUM FLOWER DRY EXTRACT PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum indicum Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linarin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
New WILD CHRYSANTHEMUM FLOWER POWDER PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum indicum Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linarin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma
