Study of compendia(i

detailed information,format,content of various type of compendia including indian ,british, united states pharmacopoiea

1. Study of compendia ( i.p ., b.p ., u.s.p ) Prepared by: yachita rajwadwala m.pharm ( q.a .)

2. contents Indian pharmacopoeia British pharmacopoeia United states pharmacopoeia 2 yachita rajwadwala

3. INTRODUCTION: Various countries have published texts, to assure drug quality which is design as compendia. Compendia lists official test methods & specification for drug product. EXAMPLES: Indian Pharmacopeias United state Pharmacopeias European Pharmacopeias British Pharmacopeias

4. pharmacopoeia Definition “Pharmacopoeia is a book or encyclopaedia of Drugs Standard, their formulas, Method for making medicinal preparation and related information's which is published under the jurisdiction of government body”

5. Need of pharmacopoeia To control the quality of medicine as per standards. To ensure the public health. To support the availability of safe, effective, good-quality pharmaceutical care for all. 5 yachita rajwadwala

6. Introduction Definition 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 for INDIA . Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC) 6 yachita rajwadwala

7. formation The Indian Pharmacopoeia Commission has been established as an Autonomous Institution under Ministry of Health & Family Welfare, Government of India on 09 th Dec. 2004. composition 7 yachita rajwadwala

8. vision To promote the highest standards of drugs for use in humans and animals within practical limits of the technologies available for manufacturing and analysis. mission To promote public health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers. 8 yachita rajwadwala

9. objective To develop comprehensive monograph for drugs to be included in Indian Pharmacopoeia, including active pharmaceutical ingredients, pharmaceutical aids, dosage form and to keep them updated To develop monographs for herbal drugs, both raw drugs and extracts Priority given to monographs of drugs included in the National Essential Drugs List and their dosage forms. Regular up gradation of monographs but consistent with the level and degree of sophistication acceptable to the majority of manufacturers. 9 yachita rajwadwala

10. Harmonization of IP standards with international acceptance criteria for drug quality Special efforts have been made to safeguard the interests of the weaker sectors of the industry without compromising the safety and efficacy of the medicines included in the Indian Pharmacopoeia (IP). 10 yachita rajwadwala

11. Presentation of IP 2007 Acknowledgements Introduction General Chapters General notices Preferences The structure of IPC 11 yachita rajwadwala

12. V olume II Deals with the general Monographs on -Drug substances -Dosage form -Pharmaceutical aids (A to M) 12 yachita rajwadwala

13. Volume III Monographs on -Drug substances -Dosage form -Pharmaceutical aids (N to Z) Followed by Monographs on Vaccines, and Immunosera for human ,Herbal and Herbal products, Blood and Blood related Products, Biotechnology products and Veterinary products 13 yachita rajwadwala

14. BRITISH PHARMACOPOEIA 14 yachita rajwadwala

15. Introduction The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK medicinal substances. The first edition of the British Pharmacopoeia was published in 1864 and was one of the first attempts to harmonize pharmaceutical standards, through the merger of the London, Edinburgh and Dublin Pharmacopoeias. 15 yachita rajwadwala

16. Since its first publication back in 1864 the distribution of the British Pharmacopoeia has grown throughout the world It is now used in over 100 countries. Australia and Canada are two of the countries that have adopted the BP as their national standard alongside the UK 16 yachita rajwadwala

17. bp mission and preface The British Pharmacopoeia contributes to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product, material or article is expected to meet any time during its period of use 17 yachita rajwadwala

18. 2007 British pharmacopoeia Official Date - 1 st January 2007 Release Date - August 2006 Official until - Next Edition The BP and its Supplement will become official six month after being released to the public 18 yachita rajwadwala

19. Presentation of British pharmacopoeia Monographs A to I Monographs J to Z 19 yachita rajwadwala

20. Volume III Formulated Preparations Blood related Preparations Immunological Products Radiopharmaceutical Surgical Materials Homeopathic Preparations 20 yachita rajwadwala

21. Volume IV Appendices I.R Spectra Index 21 yachita rajwadwala

22. Volume V Volume VI British Pharmacopoeia (Veterinary) (CD-ROM version) 22 yachita rajwadwala

23. United states pharmacopoeia and National Formulary 23 yachita rajwadwala

24. Introduction The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (Usually also called the USP) owns the trademark and copyright to the USP-NF and publishes it every 5 years. All  Prescription  and  over–the–counter  medicines and other health care products manufactured or sold in the United States are standardized to the USP-NF 24 yachita rajwadwala

25. USP also sets recognized standards for food ingredients and  dietary supplements . USP standards are recognized and used in more than 130 countries. 25 yachita rajwadwala

26. Mission and Preface The United States Pharmacopoeia promotes the public health and benefits practitioners and patients by disseminating authoritative standards and information developed by its volunteers for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery working with many constituencies and stakeholders around the world 26 yachita rajwadwala

27. history First edition December 15 th , 1820 Second edition 1830 Next each edition at 10 years interval up to 1842 Next each edition at 05 years interval from 1942 to 2000 After 2000 annually 27 yachita rajwadwala

28. The USP-NF and its supplements will become official in six months after being released to public The USP-NF, which is released on November 1 of each year, will become official on May 1 of the Next year 2007- usp-nf ( usp 30- nf 25) Release Date Nov.1 , 2006 Official Date May 1, 2007 Official until May 1, 2008 First Supplement Release Date Feb.1, 2007 Official Date Aug 1, 2007 Official until May 1, 2008 28 yachita rajwadwala

29. Second Supplement: Release Date June1 , 2007 Official Date Dec.1 , 2007 Official until May 1, 2008 29 yachita rajwadwala

30. 2007- usp-nf contains Monographs contains: -structure -tolerance limit -packaging & storage -USP reference standards -identification -melting range 30 yachita rajwadwala

31. -loss on drying -residue on ignition -other impurities -assay -dissolution & uniformity of content ( for tablets ) -pH, particulate matter(for inj.) General Tests and Assay -More than 200 General Information Chapters -Numbered above 1000 31 yachita rajwadwala

32. general chapters provide frequently cited procedures, sometimes with acceptance criteria, in order to compile into one location repetitive information that appears in many monographs 32 yachita rajwadwala

33. Presentation of USP- nf 2007 Volume 1 General Notices General Chapters Dietary supplements chapters Reagent Reference Tables Dietary supplements Monographs Monographs for drug substances and preparation 33 yachita rajwadwala

34. Volume 2 Monographs A to L Volume 3 Monographs M to Z 34 yachita rajwadwala

35. Thank you 35 yachita rajwadwala