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1. RRRRRRRRRRRRNJNBKMNLKGR
GENERAL PARAMETERS OF
MONOGRAPHS FOR HERBAL
DRUGS AND COMPARATIVE
STUDY
Department of Pharmaceutical Sciences & Natural
Products

2. CONTENTS
 Monograph introduction
 Definition
 Purpose of monograph
 Importance of content of monograph
 Introduction of various herbal monographs and
guidelines
 Comparative study of various standards

3. Herbal monographs in national pharmacopoeias and other
authorative documents play an important role in the
authentication of herbal materials.
In this context a monograph is a document that defines a
botanical drug and provides information that allows for its
proper identification.
The herbal monographs give a basic description of the
herb, and list its chemical constituents, actions, clinical uses
and recommended dosage etc.

4. The purpose of the monographs is to:
 Provide scientific information on the safety, efficacy, and
quality control/ quality assurance of widely used medicinal plant.
 Provide models to assist Member States in developing their
own monographs or formularies for these or other herbal
medicines.
 The goal of the monograph project is to protect those who
have an interest in traditional medicines (patient, prescriber,
pharmacist, manufacturer, health authority, medicines regulatory
body) against medicine of poor quality.
• .

5. TYPES OF MONOGRAPH
Herbal Monograph
Standards
monograph
Therapeutic
monograph
Combined
monograph
5

6.  Botanical features
 Distribution
 Identity tests
 Purity requirements
 Chemical assay
 Chemical constituents
Example: USP Standards Monographs
STANDARDS MONOGRAPH
6

7.  Definition Of The Plant Drug
 Clinical applications
 Pharmacology
 Contraindications
 Warnings
 Precautions
 Potential adverse reactions
 Posology ( Form of administration, Duration of use )
Examples: ESCOP (The European Scientific Cooperative On
Phytotherapy) monographs
THERAPEUTIC MONOGRAPH
7

8. Standard monograph + Therapeutic monograph
Examples:
WHO (World Health Organization) monographs
AHP (American Herbal Pharmacopeia) monographs
COMBINED MONOGRAPH
8

9. IMPORTANCE OF CONTENT OF
THE MONOGRAPHS
 DEFINITION
 SYNONYMS AND VERNACULAR NAMES
 DESCRIPTION
• Macroscopy
• Microscopy
 GEOGRAPHICAL DISTRIBUTION
 MAJOR CHEMICAL CONSTITUENTS
 IDENTITY, PURITY AND STRENGTH
It includes Foreign Matter and Quantitative tests.
The quantitative tests
 Total ash
 Acid-insoluble ash
 Water-soluble ash,
 Alcohol-soluble extractive
 Water- soluble extractive
 Ether-soluble extractive
 Moisture content
 Volatile oil content
 Bitterness valves

10.  CHROMATOGRAPHIC AND SPECTROSCOPIC EVALUATION
 PHARMACOLOGY
 CLINICAL STUDY
 TOXICOLOGY
 SAFETY
 ADVERSE DRUG REACTION

11. MONOGRAPH OF PHARMACOPOEIA
Indian Pharmacopoeia
United states of Pharmacopoeia
Ayurvedic Pharmacopoeia of India
Siddha Pharmacopoeia
Unani Pharmacopoeia
American Herbal Pharmacopeia
British Herbal Pharmacopoeia
11

12. Edition year Supplement / addendum
1- 1955 Supplement 1960
2- 1966 Suppl ement 1975
3- 1985(2 volume) Addendum 1989,1991
4- 1996(2 volume) Addendum 2000
Veterinary Supplement 2002
Addendum 2005
5- 2007(3 volume) Addendum 2008
6-2010(3 volume) Addendum 2012
7-2014(4 volume) Addendum 2015
Addendum 2016
8-2018(4 volume) Appendix 2016

13. INDIAN PHARMACOPOEIA
 First official Pharmacopeia of India appeared in 1868 which was edited by
Edward John Waring.
 In preindependence days, British Pharmacopeia was used in India.
 In 1946 Government of India issued one list known as „The Indian
Pharmacopeial List.,Committee under chairmanship of Sir R. N. Chopra
alongwith other nine members prepared „The Indian Pharmacopeiallist‟
 It was prepared by Dept. of Health, Govt. of India, Delhi in 1946.
 In 1948 Government of India appointed an Indian Pharmacopeia committee
for preparing „Pharmacopeia of India‟Tenure of this committee was five years.
 Indian Pharmacopeia committee under chairmanship of Dr. B. N. Ghosh
Published first edition of IP in 1955.

14. INDIAN PHARMACOPOEIA5Th EDITION
 Fifth edition of IP was published in 2007 & addendum to this
edition was published in 2008.
 IP 2007 is presented in Three Volumes.
 Volume One contains general notices & general
chapters.
 Volume Two & Three contains general monographs on
drug substances , dosage forms & Pharmaceutical aids.

15. INDIAN PHARMACOPOEIA 2010
 6th editionof IP is published in2010.
 The 6th edition of the Indian Pharmacopoeia 2010 is published by the Indian
Pharmacopoeia Commission (IPC) Ghaziabad in accordance with a plan and
completed through the untiring efforts of itsmembers,.
 The Indian Pharmacopoeia 2010 is presented in three volumes.
 Volume I contains the Notices, Preface, the Structure of the IPC,
Acknowledgements, Introduction, and the GeneralChapters.
 Volume II contains the General Notice, General Monographs on Dosage Forms
and Monographs on drug substances,dosage forms and pharmaceutical aids(A to
M).
 Volume III contains Monographs on drug substances, dosage forms and
pharmaceutical aids (N to Z).
 Followed by Monographs on Vaccines and Immunosera for Human use, Herbs and
Herbal products, Blood and blood- related products, Biotechnology products and
Veterinary products.
 Microbial contamination chapter updated
 NMR chapter incorporated in appendices.chapter on liposomalproducts also added

16. SEVENTH EDITION OF INDIAN PHARMACOPOEIA
 The seventh edition of the Indian Pharmacopoeia (IP 2014) is published by the
Indian Pharmacopoeia Commission (IPC) on behalf of the Government of
India, Ministry of Health & Family Welfare.
 The Indian Pharmacopoeia 2014 is presented in four volumes. The scope of the
Pharmacopoeia has been extended to include additional anticancer drugs &
antiretroviral drugs and formulations, products of biotechnology, indigenous
herbs and herbal products, veterinaryvaccines.
 The IP 2014 incorporates 2550 monographs of drugs out of which 577 are new
monographs consisting of APIs, excipients, dosage forms and herbal productsetc.
 19 New Radiopharmaceutical Monographs & 1 General chapter is first time
being included in this edition.

17. INDIAN PHARMACOPOEIA 8 EDITION 2017
 Released on 29 sept 2017 by C k Mishra
 4 volumes 220 monographs
 chemical 170
 Blood and blood related products- 10
 Vaccines and immunosera-2
 Radiopharmaceuticals -3
 Biotechnology derived therapeutic
products- 6.
 veterinary monographs -14
 366 -revised monographs
 7 –omissions
 Herbal- 15

18. Salient features of IP 2018
 General chemical test,TLC, IR, UV, HPLC has be given.
 Pyrogen test replaced by bacterial endotoxin test (BET) in parenteral
preparations.
 Index is incorporated in all volumes.
 Chapters on volumetric glasswares conductivity dissolution test
disintegration test,dimensions of hard gelatin capsule were revised.
 53 new fixed dose combinations included,out of which 25 fdc are
not available in any pharmacopoeia.
 General chapters on maintenance,identification preservation and
disposal of microrganism have been included.

19. UNITEDSTATE PHARMACOPOEIA
 First edition of United state Pharmacopeia was published on15th
 December 1820 in both Latin &English.
 From 1820 to 1942 it was published at Tenyears intervals.
 From 1942 to 2000 it was published at Five yearsintervals.
 From 2002 it was published annually.
 First National Formulary of the united state appeared in1888.
 After 1975 both USP and NF are published by united state
pharmacopoeial committee in a combined form USP-NF. USP21-
NF16 have eight supplements.
 First appeared in January 1985 & last in November1988.
 USP22-NF17, 1990 is the third revision that consolidates USP&
NF into a single volume.
 Electronic version of USP-NF on floppy disks was introduced in
1992.
 USP23-NF18, was published in Mumbai as an Asian edition at the
end of 1994.

20.  UNITED STATES PHARMACOPEIA34-NATIONAL
FORMULARY 29:USP 34-NF 29 features more than 4,500
monographs for drug substances, dosage forms, excipients, biologics,
dietary supplements, and other therapeutics.
 USP 34-NF 29 also offers harmonized material and more than 230
General Chapters with current guidelines for the full range of
laboratory tests and established processes for validating methods.
 UNITED STATES PHARMACOPEIA 35-NATIONAL
FORMULARY 30:The 'United States Pharmacopeia 35 - National
Formulary 30' (USP-NF) is a combination of two official compendia:
the 'United States Pharmacopeia (USP)' and the 'National Formulary
(NF)' and is officially applicable from 1 May, 2012 to 30 April, 2013.

21. AYURVEDIC PHARMACOPOEIA OF INDIA
 It is the legal document of standards for the quality of
Ayurvedic drugs and the substance include therein.
(Under the Drug & Cosmetic act, 1940).
 API came in existence in 1962.
 It was published in 1989.
 API has worked out monographs on the basis of genuine
and authentic drug samples approved by the physician,
manufacturing experts, and other expertise on the subject.
 At present about 1000 single drugs and 8000 compound
formulations are used in Ayurveda system including
drugs of plants, animal and mineral origin in both single
and compound formulation.
21

22. Part 2 : Vol 1
Vol 2
 These all monographs deals with the pharmacognostical, chemical and
ayurvedic standards of the plant drugs which are used in Ayurveda.
Part 1
Deals with formulation.
22
Volume No. of monographs Year
1 80 (1986)
2 78 (1999)
3 100 (2001)
4 68 (2004)
5 84 (2006)
6 101 2008
7 21 2008
8 60 2010

23. API MONOGRAPH
1.Monograph title-Sanskrit
2.Introductory para
3.Synonym-English and Urdu
4.Description
5.Identity,Purity and Strength
6.Physico-chemical parameters-TLC etc
7.Properties of action
8.Important formulation and therapeutic uses
9.Doses-metric system
10.For compound formulations
- Method of preparations
- Storage
- Physicochemical parameters

24. Plant examples :
Piper longum
Piper nigrum
Zanthoxylum alatum
Zingiber officinale
Occimum sanctum
24

25. UNANI PHARMACOPOEIA
 It is a form of traditional medicine widely practised in south
Asia.
 Unani medicine is based on the concept of 4-Humors-
Phlegem,blood,yellow bile and black bile.
 Unani Pharmacopoeia constituted in 1965.
S.NO VOLUME MONOGRAPH
1 I 45
2 II 50
3 III 53
4 IV 50
5 V 52

26. Format of Monograph
• Monograph titles
• Introductory para-Botanical name and geographical locations
• Other names-Regional name
• Description
- Macroscopy
- Microscopy
-Powder Characteristic
• Identity ,purity and Strength-TLC
• Chemical constituents
• Temperament like-Hot,moist,cold,dry etc.
• Actions-Cardiac activity(MUQAWWI-EQALB).
• Therapeutic uses
• Doses

27. Siddha Pharmacopoeia of India
• This system of medicine was developed by sages of
south india to serve humanity.
• SPI established by government of India, under APC
in 1964 under chairmanship of
Dr.C.S.Uthamarayan.
• SPI of india ,Part –I,Vol-I was printed in June-2008.
• SPI available in 2 volumes, volume I contains 73
single drug monograph and volume –II is under
progress.

28. FORMAT OF SPI MONOGRAP
Monograph Titles
Introduction
Synonyms
Descriptions
Assay
Constituents
Properties and Action
Important Formulation
Therapeutic Use
Dose

29. BRITISH HERBAL PHARMACOPOEIA
 The UK founded British Herbal Medical Association
(BHMA) in 1964 to advance the science and practice of
herbal medicines in order to ensure its statutory recognition.
 First British Herbal Pharmacopoeia (BHP) was published by
BHMA in 1971 giving monographs and quality control tests
for some of the common herbs and herbal products in the
UK,
 Revised in 1990
1996
84 monographs
169 monographs
29

30.  In 1992 BHMA published a companion British Herbal
Compendium, Volume I, which gives therapeutic
monographs on the same 84 herbs.
 BHP mainly paid attention on developing TLC techniques
for comparative identification of new botanical drugs.
30

31. Plant examples
 Aniseed
 Asafoetida
 Birch leaf
 Catechu
 Cayanne pepper
 Cehery seed
 Clove
 Devil Clove
 Aloe
 Garlic
31

32. AMERICAN HERBAL PHARMACOPOEIA
 The primary goal of the AHP is to produce authoritative herbal monographs
containing accurate, critically reviewed information on botanicals which can provide
guidance in the appropriate use of herbal therapeutics."
 The American Herbal Pharmacopoeia began developing qualitative and therapeutic
monographs in 1994, and intends to produce 300 monographs on botanicals,
including many of the Ayurvedic, Chinese and Western herbs.
 The AHP monographs are combined monographs; they include much of the standard
definitional and analytical information found in conventional pharmacopeial
monographs on standards, plus therapeutic and clinical information.
32

33. Plant examples
 Ashwagandha root
 Astragalus root
 Bilberry fruit
 Black cohosh rhizomes
 Chaste tree fruit
 Cramp bark
 Valerian root
 Ginko leaf
 Echinacea purpurea root
33

34. COMPARISION
34

35. API BHP AHP JHP WHO EMEA ESCOP
Definition       
Synonyms       
Selected Vernacular names       
History       
Description       
Plant material of
interest
      
Geographical
Distribution
      
Commercial source & handling       
Reference Standards       
General Identity Test       
Microbiology       
Chemical assay       
Instrumental       
Major chemical
constituents -
Phytochemicals
      
35

36. API BHP AHP JHP WHO EMEA ESCOP
Medicinal Values       
Pharmacology       
Contraindications       
Warnings       
Precautions       
Adverse reactions       
Posology       
References       
Clinical studies       
Regulatory guidelines
from other countries
      
36

37. 37
37
Quality
Safety
Efficacy
WHO, American herbal pharmacopoeia,
Ayurvedic pharmacopoeia of India
ESCOP
EMEA
British herbal pharmacopoeia
Japanees pharmacopoeia

38. REFERENCES
38

39. 1. http://plimism.nic.in/publication c. html.
2. www.saujanyabooks.com
3. The Ayurvedic Pharmacopoeia of India, First Edition, Government of
India, Ministry of Health and Family Welfare Department of Indian
System of Medicine and Homoeopathy , New Delhi 2006
4. Journal of American Botanical Council, 1997, issue no. 40, pg 30
5. www.herbal.ahp.org
6. http://europa.eu/agencics/commenity_agencies.htm
7. World health organization, Quality Controls Methods for Medicinal
Plant Materials. Geneva AITBS Publisher and Distributors,
Delhi2002;8-70.
8. www.Bhma.info/publication?index.html
9. http://en.wikipedia.org
10. www.escop.com
39

40. THANK YOU