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
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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.
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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)
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7. formation
The Indian Pharmacopoeia Commission has been
established as an Autonomous Institution under
Ministry of Health & Family Welfare, Government of
India on 09th Dec. 2004.
composition
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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.
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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.
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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).
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11. Presentation of IP 2007
Acknowledg
ements
Introduction
General
Chapters
General
notices
Preferences
The structure
of IPC
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12. Volume II
Deals with the general
Monographs on
-Drug substances
-Dosage form
-Pharmaceutical aids
(A to M)
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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
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14. BRITISH PHARMACOPOEIA
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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.
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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
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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
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18. 2007
British pharmacopoeia
• Official Date - 1st 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
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19. Presentation of British pharmacopoeia
Monographs
A to I
Monographs
J to Z
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20. Volume III
Formulated
Preparations
Blood related
Preparations
Immunologic
al Products
Radiopharma
ceutical
Surgical
Materials
Homeopathic
Preparations
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21. Volume IV
Appendices
I.R Spectra
Index
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22. Volume V
Volume VI
British
Pharmacopoeia
(Veterinary)
(CD-ROM
version)
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23. United states pharmacopoeia
and National Formulary
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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
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25. • USP also sets recognized standards for food
ingredients and dietary supplements.
• USP standards are recognized and used in more
than 130 countries.
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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
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27. history
• First edition December 15th , 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
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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
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29. • Second Supplement:
Release Date June1, 2007
Official Date Dec.1, 2007
Official until May 1, 2008
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30. 2007- usp-nf
contains
• Monographs contains:
-structure
-tolerance limit
-packaging & storage
-USP reference standards
-identification
-melting range
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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
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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
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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
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34. Volume 2
• Monographs A to L
Volume 3
• Monographs M to Z
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35. Thank you
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