This document provides a comparison of herbal monographs from three pharmacopoeias: the Ayurvedic Pharmacopoeia of India (API), British Herbal Pharmacopoeia (BHP), and American Herbal Pharmacopoeia (AHP). It outlines the typical contents of monographs from each, such as definitions, descriptions, chemical assays, and qualitative standards. The API focuses on ayurvedic herbs, while the BHP and AHP include Western and traditional medicine herbs. The AHP contains the most therapeutic information, while the API and BHP emphasize identification and purity. Harmonizing formats across pharmacopoeias can help ensure the quality, safety and efficacy of herbal medicines.

1. JSS Academy of Higher Education & Research
(Deemed to be University)
Accredited ‘A’ Grade by NAAC
Sri Shivarathreeshwara Nagara, Mysuru – 570 015
Karnataka, INDIA
MONOGRAPHS FOR HERBAL DRUGS
AND COMPARATIVE STUDY IN
AMERICAN & BRITISH HERBAL
PHARMACOPOEIA.
Presented By:
V. Vidya Dhari
SUB: HERBAL AND COSMETIC
ANALYSIS
GPRCP

2. CONTENTS
 Monograph introduction
 Definition
 Purpose of monograph
 Importance of content of monograph
 Introduction of various herbal monographs and
guidelines- IP,API.
 Comparative study of
1. American herbal pharmacopoeia.
2. British Herbal Pharmacopoeia.

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.
Introduction

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.
 Facilitate information exchange among Member States.
 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 HERBAL MONOGRAPH.
Herbal Monograph
5
Standards
monograph
Therapeutic
monograph
Combined
monograph

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

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
7
THERAPEUTIC MONOGRAPH

8. COMBINED MONOGRAPH
 Standard monograph + Therapeutic monograph =
Combined monograph.
Examples:
1. WHO (World Health organization) monographs
2.AHP (American Herbal Pharmacopeia)
monographs
8

9. IMPORTANCE OF CONTENT OF
THE MONOGRAPHS
 DEFINITION
 SYNONYMSANDVERNACULARNAMES
 DESCRIPTION
1.Macroscopy
2.Microscopy
 GEOGRAPHICALDISTRIBUTION
 MAJORCHEMICALCONSTITUENTS
 IDENTITY,PURITYANDSTRENGTH
-Itincludesforeignmatterandquantitativetests.
• TheQuantitativetests
 Total ash
 Acid-insoluble ash

10. Water soluble ash
Bitterness value
Loss on drying;
Water content;
 Volatile oils, etc.,
 PHARMACOLOGy
 CLINICAL STUDY
 TOXICOLOGY
 SAFETY
 ADVERSE DRUG REACTION
 CHROMATOGRAPHIC AND SPECTROSCOPIC EVALUATION

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

12. 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
along with 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.

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

14. 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.
14

15. 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.
15
Part 1
Deals with formulation.
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

16. 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

17. Plant examples :
 Piper longum- Indian Long Pepper.
 Piper nigrum –Black pepper
 Zanthoxylum alatum – Winged Prickly Ash
 Zingiber officinale - Adraka (fresh), Shunthi (dried),
 Occimum sanctum - Ocimum tenuiflorum
17

18. 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
1990
1996
18
84 monographs
169 monographs

19.  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.
19

20. Basic format of a BHP monograph
 Characteristics
Macroscopical and microscopical descriptions of the
herbal material.
 Identification
 Quantitative Standards
include limits for foreign matter, loss on drying,
total and/or acid-insoluble ash, amounts of solvent extractives and
volatile oil.
 Material of Commerce
A brief description of the form of the material and
its main geographical sources.
 Powdered Material
A description of characteristic macroscopical
and microscopical features.

21. Plant examples
 Aniseed
 Asafoetida
 Birch leaf
 Catechu
 Cayanne pepper
 Cehery seed
 Clove
 Devil Clove
 Aloe
 Garlic
21

22. 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 AHP 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.
22

23. Plant examples
 Ashwagandha root
 Astragalus root
 Bilberry fruit
 Black cohosh rhizomes
 Chaste tree fruit
 Cramp bark
 Valerian root
 Ginko leaf
 Echinacea purpurea root
23

24. COMPARISION OF BHP & AHP
24

25. API BHP AHP
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
  
25

26. API BHP AHP
Medicinal Values   
Pharmacology   
Contraindications   
Warnings   
Precautions   
Adverse reactions   
Posology   
References   
Clinical studies   
Regulatory guidelines
from other countries
   26

27. 27
27
Quality
Safety
Efficacy
WHO, American Herbal Pharmacopoeia,
Ayurvedic Pharmacopoeia Of India
ESCOP
EMEA
British Herbal Pharmacopoeia
Japanese Pharmacopoeia

28. 1. The Ayurvedic Pharmacopoeia of India, First Edition,
Government of India, New Delhi 2006.
2. Journal of American Botanical Council, 1997, issue no. 40, pg. 30
3. www.herbal.ahp.org
4. http://europa.eu/agencics/commenity_agencies.htm
5. www.Bhma.info/publication?index.html
28
REFERENCES

29. THANK YOU
THANK
YOU