PHARMACOPOEIAS

1. PHARMACOPOEIAS N.SANTHI PRIYA ASSISTANT PROFESSOR, Mpharm, Department of pharmaceutics CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

2. DEFINITION • It is a legal and official book for pharmaceutical drug specifications issued by recognized authorities usually appointed by the government of respective country • It sets standards and obligatory quality indice for drug, raw materials and various pharmaceutical products • The pharmacopoeia word is derived from 2 greek words • Pharmakon – medicine/drug +poiein- to make = DRUG MAKING

3. Pharmacopoeia • This book contains directions for the identification of samples and the preparation of compound medicnes • The descriptions of individual drug/excipient or product is called Monograph

4. IMPORTANCE OF PHARMACOPOEIA • To maintain the uniformity in standards as well as to control the adulterated medicnes, each country has its own official book i.e Pharmacopoeia • It is an important element to control the medicines licensing and inspection processes • Plays a significant role in generic drug manufacturing, contract research, production for export purpose • It is amended or updated time to time in the form of addenda/supplement or new edition where monographs of new drugs are added as well as outdated are deleted

5. Many Countries own pharmacopoeia

6. Ancient precursors to modern pharmacopoeia • Edwin smith papyrus(1862) – oldest surgical treatise (injuries, fractures,wounds,dislocations ,tumors) • 79 A.D De MateriaMedicaby Roman physician Dioscorides • The canon of medicne(Avicenna’s canon of medicine) is an encyclopedia of medicne in 5 books compiled by persian philosopher IbnSina(Avicenna) completed in 1025 • Earliest chinese pharmacopoeia :Shennung(Father of chinese medicine) –Pen ts’aoching(Divine Husbandman’s Materiamedica)

7. Classification The drug compendia are classified as : 1)Official compendia 2 ) Non-official compendia

8. Official compendia Official compendia are the compilation of drugs and other related substances which are recognized as legal standards of purity, quality and strength by government agency of respective countries of their origin. • Official compendia include • a) British Pharmacopoeia • b) British Pharmaceutical Codex • c) Indian Pharmacopoeia • d) United State Pharmacopoeia • e) National Formulary • f) The State Pharmacopoeia of USSR • g) Pharmacopoeia of other countries

9. Non-official compendia: • The books other than official drug compendia which are usedas secondary reference sources for drugs and other related substances are known as non official drug compendia. • These include • a) Merck Index • b) Extra Pharmacopoeia (Martindale) • c) The United States Dispensary

10. Indian Pharmacopoeia • Under the Drugs and Cosmetics Act 1940 , The Indian Pharmacopoeia is an official book that contains the standards for drugs and other related substances included in the pharmacopoeia. • The drugs and other related substances prepared by pharmaceutical manufacturers must comply with these standards . • For the preparation of Pharmacopoeia of India, the pharmacopoeias of other countries, like British, Europe, United States, USSR, Japan, the National Formulary (USA) and Merck Index were consulted .

11. History of development of Indian Pharmacopoeia • The government of India published the Indian pharmacopoeial list in 1946, as a supplement to the British Pharmacopoeia. • Indian Pharmacopoeial List contain list of drugs both included and not included in the British Pharmacopoeia along with standards to secure their usefulness, tests for identity and purity. • The Govt. of India constituted a permanent Indian Pharmacopoeia Committee in 1948 . • This committee was assigned the task of preparing Indian Pharmacopoeia and to keep it up-to-date.

12. Editions of Indian Pharmacopoeia Indian Pharmacopoeia • 1955 - First edition , followed by supplement in 1960 • Indian Pharmacopoeia 1966 - Second edition , followed by supplement in 1975 • Indian Pharmacopoeia 1985 - Third edition , followed by its addendum in 1989 and 1991 • Indian Pharmacopoeia 1996 - Fourth edition , followed by its addendum 2000, supplement 2000 for Veterinary Products, addendum 2002 and addendum 2005 • Indian Pharmacopoeia 2007 - Fifth edition , followed by addendum 2008 • Indian Pharmacopoeia 2010 - Six edition , followed by its addendum 2012 • Indian Pharmacopoeia 2014 with DVD - Seventh edition

13. Number of volumes in each edition of IP • IP 1955, 1965 and 1985 was published in 1 volumes • IP 1996 was published in 2 volumes • IP 2007 and 2010 was published in 3 volumes • IP 2014 was published in 4 volumes

14. Contents of the IP 2014 Volume-1 • Introduction General Chapters • General Notices • Test Methods • Apparatus • Biological Methods • Chemical Methods • Physical and Physicochemical Methods • Pharmaceutical Methods • Tests on Herbal Products • Tests on Vaccines • Tests on Blood and Blood Blood-related Products • Reference Data • Reagents and Solutions • General Tests • Containers • Tables

15. Contents of the IP 2014 Volume-2 • General Notices General Monographs on Dosage Forms Monographs on Drug substances, Dosage forms and Pharmaceutical Aids • Monographs A to M

16. Contents of the IP 2014 Volume-3 • General Notices • Monographs on Drug substances, • Dosage forms and Pharmaceutical aids • Monographs N to Z • Monographs on Vaccines and Immunosera for Human Use • Monographs on Herbs and Herbal Products • Monographs on Blood and Blood Blood related Products • Monographs on Biotechnology Products

17. Contents of the IP 2014 Volume-4 • Monographs on Veterinary Products o • Non Non-Biological • Biological • Diagnostics Index

18. MONOGRAPH Title of the Monograph : The main name of the substance (The International Non-proprietary Name (INN) approved by the World Health Organization (WHO )). Subsidiary or abbreviated title or synonym : The common name(s), if any, of the substance. Chemical formula and Molecular Weight of the substance : If necessary, its I.U.P.A.C. chemical name and/or its chemical structure is also given . Standards: Prescribes the standards of purity and strength e.g. Sodium bicarbonate IP contains not less than 99.0 % and not more than 100.5 % of NaHCO3. Description: A brief description of the physical form of the material, including colour, texture, whether hygroscopic, odour, if readily apparent, and any other characteristic

19. MONOGRAPH Solubility : Identification: At least two or three identification tests, starting with physical and instrumental tests and ending with general chemical reactions is given. Tests of purity: These tests include melting point, boiling point, weight per ml, limit tests for chloride, sulfates , iron, heavy metals, lead and arsenic, specific optical rotation, sulfated ash, loss on drying, pH of solution, etc. as may be applicable for the substance. Method of Assay: The term ‘Assay’ is used in pharmacopoeias for quantitative determination of principal ingredients of the official substances and of their preparations. Storage: Prescribes some conditions for the storage of some official substances which are likely to deteriorate if not properly stored.

20. NATIONAL FORMULARY OF INDIA • The National Formulary of India would prove to be the authoritative guide to prescribing, dispensing and administering medicines for all healthcare professionals. The National Formulary of India editions are as follows: - • National Formulary of India 1960 -The first edition of NFI • National Formulary of India 1966 -The Second edition of NFI • National Formulary of India 1979 –The Third edition of NFI • National Formulary of India 2011-Fourth Edition It contains information about drug interaction, resistance, cumulative effects, drug dependence, prescription writing etc.

21. CONTENTS OF NATIONAL FORMULARY OF INDIA • List of Medicines in NFI • Common Abbreviations • General Advice to Prescribers • Alphabetical listing of different classes of drugs with Indications . • Availability • Dose . • Contraindications • Precautions • Adverse effects • Storage • Appendices • Index

22. The British Pharmacopoeia • The British Pharmacopoeia (B.P.) It was first published in 1864. • Since 1948, which is seventh edition of B.P. the new edition of British Pharmacopoeia is published at intervals of five years i.e. 1948, 1953, 1958, 1963, 1968, 1973. • After 1973 the new edition was published in 1980 and then in 1988, 1993, 1998, 2003, 2008. • After 2008 the new edition was published every year. • In addition to the publication of the pharmacopoeia, the addendums are also published from time to time in between two main editions. • The BP contains monographs, which set out the mandatory standards for active substances, excipients and formulated preparations, together with General Notices, Appendices (test methods, reagents, etc ) and Reference Spectra

23. The British Pharmacopoeia • Volumes I and II Medicinal Substances • Volume III Formulated Preparations Blood related Preparations Immunological Products Radiopharmaceutical Preparations Surgical Materials Homeopathic Preparations • Volume IV Appendices Infrared Reference Spectra Index • Volume V British Pharmacopoeia (Veterinary) • Volume VI (CD-ROM version) British Pharmacopoeia

24. The British Pharmaceutical Codex The British Pharmaceutical Codex differs from British Pharmacopoeia in that : • It contains many more drugs and preparation • It provides standards for drugs surgical dressings and pharmaceutical preparations not included in the British Pharmacopoeia. • It provides information on the actions and uses of drugs, their undesirable effects, precaution and treatment of poisoning. • It contain formulae, method of preparation, dose, container and storage conditions of most of the preparations which are still extemporaneously prepared in the pharmacy and dispensed by the pharmacists. • These preparations include mixtures, powders, eye drops, ear drops, liniments, lotions, ointments, creams, pastes, suppositories etc.

25. United State Pharmacopoeia- National Formulary • The United States Pharmacopoeia and National Formulary (USP-NF) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. • USP also sets recognized standards for food ingredients and dietary supplements. • The United States Pharmacopoeia was originally published in 1820 under the authority of the United States Pharmacopoeial Convention and the National Formulary was published in 1888 under the guidance of American Pharmaceutical Association . • In 1974 the National Formulary was purchased by the United States Pharmacopoeial Convention and from 1980 onwards only one official book of drug standards was published under the heading, The United States Pharmacopoeia and The National Formulary (USP-NF).

26. United State Pharmacopoeia- National Formulary • The USP–NF is a three volume combination of two official compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). • Monographs for drug substances and preparations are featured in the USP. • Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF.

27. EXTRA PHARMACOPOEIA (MARTINDALE) • The Extra Pharmacopoeia was first produced in 1883 by William Martindale and is still known as ‘Martindale ’ Published by The Royal Pharmaceutical Society of Great Britain • The term “Extra” means in this instance “Outside”, because the book aimed to describe drugs that were outside the British Pharmacopoeia.

28. THE MERCK INDEX • It is an encyclopedia of chemicals, drugs and biologicals . • The first edition was published in 1889 and the eleventh edition was published in 1989 by Merck & Co., Inc. Rahway, New Jersy , USA. • The Merck Index is the definitive reference work for scientists and professionals looking for authoritative information on chemicals, drugs and biologicals .