Description about what is pharmacopoeia? different pharmacopoeia and there edition. What is monograph and there comparative studies in different pharmacopoeias along with monograph format in per different pharmacopoies.

1. Presented By: Shikha Bhardwaj
M.Pharmacy
1st Semester
(Pharmacognosy)

2. WHAT IS A
PHARMACOPOEIA ?
o Pharmacopoeia: the word derives from the ancient
Greek word pharmakon-drug & poeia- to make.
o It is a legally binding, collection, prepared by a
national or regional authority & contains list of
medicinal substances, crude drug & formulas for
making preparation from them.

3. The pharmacopoeia contain:-
 List of drug and other related substances
 Sources
 Description
 Tests
 Formulas for preparation
 Uses
 Doses
 Storage conditions

4. o Definition: a detailed written study of a single specialized
subject or an aspect of it .
or
o A monograph is a book ,pamphlet or document that is
complete in itself .
• Researchers publish their findings in monographs so their
peers can review and validate their findings.
MONOGRAPH

5. Provide a
reliable basis for
judging the
quality of the
drug substances
Way to control
Adulterated
and
contaminated
medicines
Set
standards
for the
quality ,
purity ,
strength
 Concise description of a
single substances
 Reference for
pharmaceutical drug
specifications

6. INDIAN PHARMACOPOEIA


7.  As per the Drugs and Cosmetics Act 1940, the Indian
Pharmacopoeia legally recognized book of Standards for
the quality of drug substances and preparations included
therein.
 Published by the Indian Pharmacopoeia Commission
which is an Autonomous Institution under the Ministry of
Health & Family Welfare, Govt. of India.
 Sole authority for all prescription and over – the –
counter medicines and other health care products
manufactured or sold in India.

8. EDITION YEAR OF
PUBLICATION
SUPPLEMENT CHAIRMAN
I 1955 1960 Dr.R.N CHOPRA
II 1966 1975 Dr. B. MUKHERJI
III 1985 1981 Dr. NITYANAND
1991
IV 1996 2000 Dr. NITYANAND
2002
V 2007 2008 Dr. NITYANAND
V1 2010 2012 Dr. Ghulam Nabi
Azad
V11 2014 2015 Dr. Ghulam Nabi
Azad
2016
V111 2018 _ Dr. P. K. Pradhan

9. Monograph Developed
0
500
1000
1500
2000
2500
3000
3500
1985 1996 2007 2010 2014 2018
Column1
Column1

10. MONOGRAPH FORMAT
• Name: Drug name ,Chemical Formula
• Chemical Name: According to IUPAC
• Category: Medicinal & Pharmaceutical Aid
• Description: Macroscopic & Microscopic features
• Solubility: Aqueous or organic solvents

11. o Standards –, TLC identification.
For TLC, reference solution is a certified sample of
genuine drug supplied by IPC.
o TESTS – a)foreign organic matter
b)Ethanol soluble extractive
c)Water soluble extractive
d)Ash value
e)Acid insoluble ash

12. e) Heavy metals
f) Loss on drying
g) Microbial contamination
o Assay
o Labeling of drugs
o Specific storage conditions.

13. AYURVEDIC PHARMACOPOEIA
OF INDIA

14.  Ayurveda is a holistic system of healing which evolved among
Brahmin sages of ancient India some 3000-5000 years ago.
 It focuses on establishing & maintaining balance of the life
energies within us rather than focusing on individual.
 API came into existence in 1962.
 At present about 1,000 single drugs and 8,000 compound
formulations are used in the Ayurveda system including drugs of
plants, animal and mineral origin both single and compound
formulations.

15. Publication of Ayurvedic Pharmacopeia year No. of drugs
1.) Ayurvedic Pharmacopoeia of India Vol. I 1986 80
2.) Ayurvedic Pharmacopoeia of India Vol. II 1999 78
3.) Ayurvedic Pharmacopoeia of India Vol. III 2001 100
4.) Ayurvedic Pharmacopoeia of India Vol. IV 2004 68
5. ) Ayurvedic Pharmacopoeia of India Vol. V 2006 92
6.) Ayurvedic Pharmacopoeia of India Vol. VI 2008 101
7. Ayurvedic Pharmacopoeia of India Vol. VII
( Minerals and Metals)
2008 21
8.)Ayurvedic Pharmacopoeia of India Vol.V111 2010 60

16. o MONOGRAPH TITLE :-
name given on the top of each monograph is given in Sanskrit.
o INTRODUCTORY PARA :-
Botanical name along with part used .
Geographical source.
o SYNONYM :-
Mentioned in English & Urdu.

17. o DESCRIPTION :-
Macroscopy
Microscopy
Powder characteristic
o IDENTITY, PURITY AND STRENGTH –
Foreign matter
Total ash
Acid insoluble ash & Extractive value are determined.
o Physico-chemical Parameters
o T.L.C :-
Number of spot (Rf VALUE) determine identity.
o CONSTITUENTS :-
o PROPERTIES AND ACTION:-
Pharmacological principle

18. o IMPORTANT FORMULATION AND THERAPUTIC USES:-
Ayurvedic formulary
Ayurvedic classic
o DOSES:-
In metric system
Method of preparation
Storage
Physiochemical parameters

20.  It is a form of traditional medicine widely practiced in south
Asia.
 Unani medicine is based on the concept of 4 humors-phlegm,
blood, yellow bile & black bile
 UPI constituted in 1965.

21. S.NO PUBLICATION OF UNANI PHARMACOPOEIA NO.OF
DRUGS
1.) Unani Pharmacopoeia of of India Vol I 45
2.) Unani Pharmacopoeia of India Vol II 50
3.) Unani pharmacopoeia of India Vol III 53
4.) Unani pharmacopoeia of India Vol IV 50
5.) Unani pharmacopoeia of India Vol V 52
Development of
Publication

22. FORMAT OF MONOGRAPH
o MONOGRAPH TITLE :-
The name given on the top of each monograph is in unani.
Unani name along with the part used in the bracket underneath it.
o INTRODUCTORY PARA :-
Botanical name and geographical location.
o OTHER NAME :-
Include name in regional language
o DESCRIPTION :-
Macroscopy
Microscopy
Powder characteristics.

23. o IDENTITY, PURITY AND STRENGTH :-
Foreign matter
Total ash
Acid insoluble ash
o T.L.C :-
Number of spots ( Rf values ) are determined
o CHEMICAL CONSTITUENTS :-
Name of the constituents are mentioned.
o TEMPERAMENT like hot, moist, cold, dry etc. are mentioned.
o ACTION :-
MUQAWWI-E-QALB (CARDIAC TONIC)
MUQUAWWI-E-JIGAR (LIVER TONIC )

24. o THERAPEUTIC USE :-
MENTIONED IN ARABIC AND ENGLISH
Example :- ZOF-E-ALAM (GENERAL
WEAKNESS)
o DOSE :-
Given in gm OR ml

25. SIDDHA
PHARMACOPOEIA

26. o This system of medicine was developed by sages of south
India to serve humanity.
o SPI established by Government of India under APC in 1964
under chairmanship of Dr.C.S Uthamarayan.
o Siddha pharmacopoeia of india ,part I, vol I was printed in
June 2008..
o Available in 2 volumes volume I contains 73 single drug
monographs & volume II is under progress.

27. FORMAT OF S.PI
MONOGRAPH
 MONOGRAPH TITLE:-
The name given on the top of each monograph is in Tamil.
 INTRODUCTION :-
Botanical name & part used with geographical source & brief
description about cultivation & collection is also mentioned.
 SYNONYM :-
Synonyms in other Indian regional languages.
 DESCRIPTION :-
macroscopy
microscopy
powder microscopy.

28.  ASSAY :-
TLC ANALYSIS
HPLC& HPTLC ANALYSIS.
 CONSTITUENTS :-
Important constituents are mentioned
 PROPERTIES AND ACTION :-
Mentioned in Tamil
 IMPORTANT FORMULATION :-
MENTIONED IN SIDDHA CLASSICS
 THERAPEUTIC USE :-
 DOSE :-
MENTIONED IN gm OR ml

29. BRITISH HERBAL
PHARMACOPOEIA

30. • The BHP is a very useful aid to quality assurance,
particularly for herbs not featured in official
pharmacopoeias.
• Prepared by British herbal medicine association in 1964.
• Two volumes of British herbal compendium vol 1 & vol
2.
• 1983 edition contain 233 monograph on single herbal
drug and BPH 1996 provided quality standard for 169
herbal raw materials.

31. Format for monograph
 Title:
name of drug
family of drug
 Synonym:
given in English
 Introduction:
Biological source of drug
 Characteristic:
macroscopic
microscopic

32.  Identification:
Identification tests
TLc Method
 Quantative standard:
foreign matter
total ash
acid soluble ash
 Material of commence:
form in which drug is supplied
place of collection

33.  Powdered Drug: characteristic of powder
 Action: mode of action
 Storage

34. JAPANESE
PHARMACOPOEIA

35. JP is published by the Japanese government, the ministry
of health, labour and welfare ministerial notification.
First published on June 25,1886 and implemented on July
1,1887.
JP is published in accordance with the provisions of
article 41-1 of the Pharmaceutical affairs law (PAL)
Japan.

36. Format of monograph
 English title
 Commonalty used name
 Latin title
 Title in Japanese
 Structural formula
 Limit of content of ingredient
 Labelling requirement
 Method of preparation

37.  Description
 Identification tests
 Purity test
 Special test
 Assay
 Container and storage

38. UNITED STATE
PHARMACOPOIES

39.  USP is a pharmacopoeia for the united states published
annually by united states pharmacopoeial convention.
 It contains standards for medicines, dosage forms, drugs
substances, excipients, biologics, compounded
preparations, medical devices, dietary supplements, and
therapeutics.

40. Format of monograph
 Name
 Added substance
 Description
 Solubility
 Identification tests
 Assay
 Impurities and foreign substances
 Performance tests
 Storage conditions

41. COMPARATIVE STUDY
S.NO I.P A.P.I U.P S.P.I BHP J.P USP
TITLE BOLD
ENG.
SANSKRIT UNANI TAMIL ENG. ENG. ENG.
SYN. ENG. SANSKRIT PER.&ARA
B
TAMIL ENG. ENG. ENG.
DESC. + + + + + + +
ASSAY + _ _ + _ + +
ACTION + SANS ARAB TAMIL + _ +
STORAGE + _ _ _ + + +
DOSE + + + + _ _ _
TEMP. _ _ + _ _ _ _
I.TEST + + + + + + +
MICROB.
CONT.
+ _ _ _ + + +
HEAVY
METAL
+ _ _ _ + + +

42. 1. Indian Pharmacopoeia
2. Ayurvedic Pharmacopoeia
3. Siddha Pharmacopoeia
4. Unani Pharmacopoeia
5. United state Pharmacopoeia
6. Japanese Pharmacopoeia
7. www.ipc.nic.in
8. www.wikipedia.com