NEW EDITION OF IP : NEW EDITION OF IP : THE IP 2007THE IP 2007

ByDr G N SinghDr G N Singh

Secretary-cum- Scientific Director Secretary-cum- Scientific Director Indian Pharmacopoeia CommissionIndian Pharmacopoeia Commission

GhaziabadGhaziabad

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• Substandard drugs are available in the market worldwide.

• WHO estimates that counterfeit drugs account for approximately 5-8% of the total worldwide trade in pharmaceuticals.

MENACE OF SUBSTANDARD DRUGS

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Chemical instability Inappropriate storage and transport

Poor quality control during mfg. Those drugs which have been tampered with,

Drug resistance adulterated, diluted, repackaged, relabelled

Treatment failure

Substandard/ Counterfeit drugs

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• Indian Pharmacopoeia is the compilation of official standards of drugs and pharmaceuticals manufactured in India and/ marketed in India.

• As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is the legally recognized Book of Standards for the quality of drug substances and preparations included therein.

IP PLAYS A VITAL ROLE IN QUALITY IP PLAYS A VITAL ROLE IN QUALITY CONTROL OF DRUGSCONTROL OF DRUGS

• The Standards of IP are legally enforceable.

• IP Contains the Standards in the form of Monographs.

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Edition Year of Publication Main edition Addenda

I 1955Addendum to IP 1955 1960

II 1966Addendum to IP 1966 1975

III 1985Addendum to IP 1985 1989 & 1991

IV 1996Addendum to IP 1996 2000 Vet. Suppl. 2000

2002

Chronology of Publication of IPChronology of Publication of IP

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Addendum to IP 1996 2005

V Edition 2007 (In Press)

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The new edition of IP (IP 2007) has been prepared by the Indian Pharmacopoeia Commission in accordance with a plan and completed through the untiring efforts of its members & secretariat

over a period of ~ 2 years.

It supersedes 1996 edition.

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UpgradationUpgradation

• General Notices contents

• Monographs of IP 1996 : 1250

• Appendices : 300

• General Analytical Methods : 300

• New Drugs Monographs : 250

(API + Dosage Forms)

• Omissions : 13

NEW EDITION IP 2007

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• 3 Hard bound volumes bearing IPC seal and a book number representing the official print version.

• Printed by NISCAIR (National Institute of Science Communication and Information Resources), Pusa, New Delhi.

PRESENTATIONPRESENTATION

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Volume I

Notice

Preface

Structure of IPC

Acknowledgements

Introduction

General Chapters

CONTENTSCONTENTS

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Volume II

Monographs on Drug Substances, Dosage Forms and

Pharmaceutical

Aids (A to M).

Volume III

Monographs on Drug Substances Dosage Forms and

Pharmaceuticals Aids (N to Z) followed by Monographs on :

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• Vaccines and Immunosera for Human Use

• Herbs and Herbal Products

• Blood and Blood related Products

• Biotechnology Products

• Veterinary Products (form an integral part, previously these were published as a Supplement to IP 1996

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Scope of Pharmacopoeia extended to include

• Products of Biotechnology,

• Herbs and Herbal Products,

• Viral Vaccines,

• Additional Antiretroviral Drugs & Formulations (inclusive of Fixed dose combinations)

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• 2 Column format.

• More user friendly.

• Cross referencing avoided in monographs.

• No multiplicity of fonts.

• Uniformity of presentation of subject matter.

FORMATFORMAT

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• The standards laid down represent the minimum with which the article must comply.

• It is incumbent on the manufacturer to ensure that the article is manufactured in accordance with GMP.

BASIS OF PHARMACOPOEIAL BASIS OF PHARMACOPOEIAL REQUIREMENTSREQUIREMENTS

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• It is essential that sufficient stringent limits are applied at the time of release of a batch of a material/product so that the pharmacopoeial standards are met until its expiry date under the storage conditions specified.

• Valid interpretation of any requirement of Pharmacopoeia is a must and General Notices will facilitate the correct application of the requirements.

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• Category of drugs, dosage and usual strength of dosage forms omitted.

• Solubility: Presented as separate section for all APIs and Pharmaceutical Aids.

• Title of monographs : Presented in shorter form.

CHANGESCHANGES

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• Classical chemical tests of identification of an article eliminated.

• Specific tests - IR & UV Spectrophotometric tests included.

• Chromatographic methods : Greatly extended to detect impurities in products.

• Pyrogen test : Virtually eliminated. Bacterial Endotoxin Test (BET)- Applicable to more items.

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Volume I • Devoted to test methods applicable to all

articles of Pharmacopoeia & General information.

• Reference spectra• Typical Chromatogram• Analytical methods included are internationally

accepted methods to increase Global acceptance of a product.

• Section on Containers for Pharmaceutical use has been enlarged.

GENERAL CHAPTERSGENERAL CHAPTERS

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• General monographs for dosage forms of API are grouped together at the beginning of Volume II.

• Monographs of API and their dosage forms are given in Volume II & III

GENERAL MONOGRAPHSGENERAL MONOGRAPHS

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Monographs General

Chapter

Vaccines for Human Use 45 1

Blood Products 21

Biotechnology Products 04 1

Veterinary Vaccines 41 1

Veterinary Diagnostics 14

BIOLOGICAL PRODUCTS

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VACCINES FOR HUMAN USE

Total monographs incorporated in IP 2007 : 45

Bacterial vaccines : 13

Viral vaccines : 16

Mixed Vaccines : 16

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S. No. Monographs IP 1996 IP 2007

1 Dried Human Antihaemophilic Fraction √ √

2 Human Albumin √ √

3 Anti-A Blood Grouping Serum √

4 Anti-B Blood Grouping Serum √

5 Anti-Human Globulin Serum √

6 Anti-D Immunoglobulin Human for Intravenous Use

√

BLOOD PRODUCTS MONOGRAPHS = 21

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7 Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e

√

8 Cryoprecipitated Antihemophilic Factor √

9 Fibrin Sealant Kit √

10 Human Coagulation Factor IX √

11 Human Coagulation Factor VII √

12 Human Coagulation Factor VIII (rDNA) √

13 Human Normal Immunoglobulin

√ √

14 Human Prothrombin Complex √

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15 Human Plasma for Fractionation √

16 Human Plasma Protein Fraction

√ √

17 Concentrated Human Red Blood Cells √ √

18 Anti-D (Rho) Immunoglobulin

√

19 Platelet Concentrate √

20 Whole Human Blood √ √

21 Normal Immunoglobulin for Intravenous Use

√

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S. No. Monographs IP 1996 IP 2007

1 Erythropoietin Concentrated Solution x √

2 Filgrastim Concentrated Solution x √

3 Interferon Alfa-2 Concentrated Solution x √

4 Streptokinase Bulk Solution x √

BIOTECHNOLOGY PRODUCTS

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Total Veterinary Vaccines Monographs : 41

New Veterinary Vaccines : 05

New Veterinary Drugs : 02

Rest of the Veterinary Monographs have been

put into new format.

VETERINARY PRODUCTS

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1. Clostridium Multicomponent Vaccine, Inactivated

2. Inclusion Body Hepatitis (IBH) Vaccine, Inactivated

3. Infectious Coryza Vaccine

4. Laryngotracheitis Vaccine, Live

5. Peste Des Petitis Ruminants Vaccine, Live

6. Ivermectin

7. Ivermectin Injection

NEW VETERINARY VACCINES AND VETERINARY DRUGS MONOGRAPHS

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1. Amalaki 7. Coleus

2. Amra 8. Gokhru

3. Arjuna 9. Gudmar

4. Artemisia 10. Guduchi

5. Bhibhitaki 11. Haritaki

6. Bhringraj 12. Tulasi

HERBS AND HERBAL PRODUCTS HERBS AND HERBAL PRODUCTS

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13. Kutki 19. Punarnava

14. Lasuna 20.Sarpagandha

15. Manjistha 21. Shatavari

16. Maricha 22. Shati

17. Pippali Large 23. Kunduru

18. Pippali Small

HERBS AND HERBAL PRODUCTS HERBS AND HERBAL PRODUCTS

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1. Astemizole

2. Astemizole Tablets

3. Diazepam Capsules

4. Fenfluramine Hydrochloride

5. Fenfluramine Hydrochloride Tablets

6. Pectin

OMISSIONS OMISSIONS

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7. Phenformin Hydrochloride

8. Phenformin Hydrochloride Tablets

9. Succinylsulphathiazole

10.Succinylsulphathiazole Tablets

11.Sulphacetamide Sodium Eye Ointment

OMISSIONS OMISSIONS

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Supporting Structure for theIndian Pharmacopoeia Commission