monographs of herbal drugs

1. Submitted to:
Dr . Rupshee Jain
Asso.Professor
Pharmaceutical Analysis.
JSS College Of Pharmacy, Mysuru
Submitted by:
N. Surendra chowdary
M. Pharm, 1st Year
Pharmaceutical Analysis.
JSS College Of Pharmacy, Mysuru
STUDY OF MONOGRAPHS OF HERBAL DRUGS AND
COMPARITIVE STUDY IN I.P, U.S.P, A.H.P AND B.P .

2. Contents :
• What Is Pharmacopoeia?
• What Is Monograph?
• Types Of Monographs
• Indian Pharmacopoeia And Its Monograph Format With Example
• United States Pharmacopeia And Its Monograph Format With Example
• American Herbal Pharmacopeia And Its Monograph Format With Example
• British Pharmacopoeia And Its Monograph Format With Example
• Comparative Study
• References

3. WHAT IS PHARMACOPOEIA?
• 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.
Pharmakon
(Drug)
Poeia
(To make)
Pharmacopoeia

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

5. TYPES OF MONOGRAPHS:
• Botanical features
• Distribution
• Identity tests
• Purity requirements
• Chemical assay
• Chemical constituents
E.g.:
USP standards monograph
STANDARD
MONOGRAPH
THERAPETUIC
MONOGRAPH
COMBINED
MONOGRAPH
• Standard monograph
+
Therapeutic monograph
E.g.:
1.WHO monographs
2.AHP(American Herbal
Pharmacopeia) monographs.
• Definition Of The Plant Drug
• Clinical applications
• Pharmacology
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Posology
( Form of administration,
Duration of use )
E.g.: ESCOP
(The European Scientific
Cooperative On Phytotherapy)
Monographs.

6. INDIAN PHARMACOPOEIA
• 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
HISTORY :
• The pharmacopoeia originated as the Bengal Pharmacopoeia & General Conspectus of Medicinal
Plants, 1844 & was known as the Bengal Pharmacopoeia.
• The first pharmacopoeia was published in 1868 under the authority of the Secretary of State for
India.
• It contained standards for drugs official in the British Pharmacopoeia (BP) 1867 & a few selected
indigenous drugs.
• The recognition of a pharmacopoeia as the official book of drug standards came only with the
process of passing legislation of the Drugs and Cosmetics Act in 1940.
• After independence an Indian Pharmacopoeia Committee, a permanent body was constituted in 1948
and it prepared the Pharmacopoeia of India (The Indian Pharmacopoeia) 1955.

7. Development of Indian Pharmacopoeia:
EDITION YEAR OF
PUBLICATION
SUPPLEMENT CHAIRMAN
First 1955 1960 DR. R.N. Chopra
Second 1966 1975 DR. B. Mukherji
Third 1985 1981 DR. Nityanand
Fourth 1996 2000 DR. Nityanand
Fifth 2007 2008 DR. Nityanand
Sixth 2010 2012 DR. Ghulam Nabi
Azad
Seventh 2014 2015 DR. Ghulam Nabi
Azad
Eight 2018 - DR. P.K. Pradhan

8. I.P. MONOGRAPH FORMAT:
Title
Biological Source
 Synonyms
Category
• Medicinal & Pharmaceutical Basis
Description
Identification Test
• Macroscopic
• Microscopic
 Reference Substance And
Standard Preparation
 Quantitative Tests
• Foreign organic matter
• Ethanol-soluble extractive
• Water-soluble extractive
• Ash value
• Acid-insoluble value
• Heavy metals
• Microbial contamination
• Loss on drying etc.
 Assay Procedure
Storage Condition
 Labelling.

9. E.g. Ashwagandha:
Synonym: Indian Ginseng, Withania
Biological Source: Ashwagandha consists of the dried mature roots of Withania somnifera Dunal
(Fam. Solanaceae).
Ashwagandha contains not less than 0.02 per cent of total withanolide A and withaferin A, calculated
on the dried basis.
Description: Buff to greyish-yellow roots. Taste, slightly mucilaginous, bitter and acrid.
Identification:
A. Macroscopic — Primary roots are straight, conical or finger like in shape, variable in thickness
with the age. Secondary roots are thin and fibrous. Surface buff to greyish-yellow with
longitudinal wrinkles.
B. Microscopic — Vessels with bordered pits and horizontal perforations. Fibres aseptate with
pointed ends. Wood elements lignified. Starch grains abundant, simple, mostly spherical, reniform
– oval with central hilum. Microcrystals in parenchyma cells
Reference solution: Reflux 0.6 g of coarsely powdered ashwagandha RS with 10 ml methanol for 15
minutes, cool and filter.

10. Quantitative Tests:
Foreign organic matter : Not more than 2.0 per cent.
Ethanol-soluble extractive : Not less than 10.0 per cent.
Water-soluble extractive : Not less than 15 per cent
Ash value : Not more than 7.0 per cent.
Acid-insoluble ash : Not more than 1.2 per cent.
Heavy metals : 1.0 g complies with the limit test for heavy metals, Method B (20
ppm).
Loss on drying : Not more than 12.0 per cent, determined on 5 g by drying in an oven
at 105o.
Microbial contamination : Complies with the microbial contamination tests.
Assay : Determine by liquid chromatography
Storage : Store protected from heat, moisture and against attack by insects and
rodents.

11. United States Pharmacopeia
• USP – United States Pharmacopeia, a private, non-profit and non-governmental organization.
• USP is recognized as the official compendium for drugs in the U.S. according to the Federal
Food Drug & Cosmetic Act.
• USP sets the standards for drug identity, strength and purity.
• FDA enforces the standards set by USP.
History:
• The first printing of the U.S. Pharmacopeia was in 1820.Since then, 43 editions have been
published. The current version, USP–NF 2023, Issue 1, will become official on May 1, 2023.
• In 1975, USP acquired the National Formulary (NF), which contains excipients standards
• USP acquired the Food Chemicals Codex ( FCC) in 2006

12. U.S.P. MONOGRAPH FORMAT:
Title
Definition
• Biological Source
 Identification Test
• TLC
• HPLC
Composition
• Sample Substance And
Standard Preparation
 Contaminants
• Elemental impurities and
their acceptance criteria for Ar, Cd, Pb, Hg
• Microbial enumeration tests
• Absence of specified microorganisms
 Specific tests
• Botanic characteristics
 Macroscopic
 Microscopic
 Quantitative Tests
• Foreign organic matter
• Ethanol-soluble extractive
• Water-soluble extractive
• Ash value
• Acid-insoluble value
• Heavy metals
• Microbial contamination
• Loss on drying etc.
 Additional Requirements
• Packaging and Storage Condition
 Labelling.
Ref: https://online.uspnf.com/uspnf/document/1_GUID-8E8EA70F-3323-41B8-A509-706F245B4C7E_2_en-US

13. E.g. Banaba Leaf:
DEFINITION:
Banaba Leaf consists of the dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae). It
contains NLT 0.2% of corosolic acid (C30H48O4 ), calculated on the dried basis.
IDENTIFICATION
Thin-layer chromatography
Standard solution A: 0.2 mg/mL of USP Corosolic Acid RS in methanol Standard solution B: 10
mg/mL of USP Lagerstroemia speciosa Leaf Dry Extract RS in methanol. Sonicate for 10 min,
centrifuge, and use the supernatant.
Sample solution: About 0.2 g of Banaba Leaf, finely powdered, in 10 mL of methanol. Sonicate
for 15 min, centrifuge, and use supernatant.
Chromatographic system
Mode : HPTLC
Adsorbent : Chromatographic silica gel mixture with an average particle size of 5 µm
(HPTLC plates)
Application volume: 6 µL each of Standard solution A and Standard solution B and 8 µL of the
Sample solution as 8-mm bands

14. Relative humidity: Condition the plate to a relative humidity of about 33% using a suitable device.
Developing solvent system: A mixture of toluene, ethyl acetate, and acetic acid (55: 45: 0.5)
Derivatization reagent: 85 mL of ice-cooled methanol mixed with 10 mL of glacial acetic acid, 5 mL of
sulfuric acid, and 0.5 mL of p-anisaldehyde
COMPOSITION
Content of corosolic acid
Solution A : Dilute 0.1% phosphoric acid in water.
Solution B : Acetonitrile
Mobile phase : A mixture of Solution A and Solution B (4:6) Standard solution A: 0.1 mg/mL of USP
Corosolic Acid RS in methanol
Standard solution B: 5.0 mg/mL of USP Lagerstroemia speciosa Leaf Dry Extract RS in methanol.
Sonicate if necessary. Before injection, pass through a membrane filter of 0.45-µm or finer pore size.
Discard the first few mL of the filtrate.
Sample solution: Transfer about 5.0 g of Banaba Leaf, finely powdered and accurately weighed, to a
round-bottom flask. Add 75 mL of methanol, reflux for 15 min, set aside to settle, and decant the
supernatant. Repeat the extraction three more times, then combine the extracts. Filter, and concentrate
under reduced pressure. Transfer to a 100-mL volumetric flask, adjust with methanol to volume, and
mix. Before injection, pass through a membrane filter of 0.45-µm or finer pore size. Discard the first few
mL of the filtrate.

15. Chromatographic system
Mode: LC
Detector: UV 205 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Column temperature: 25°
Flow rate: 1.6 mL/min
Injection volume: 20 µL
Acceptance criteria: NLT 0.2% of corosolic acid on the dried basis
1.4. CONTAMINANTS
Arsenic: NMT 2.0 µg/g
Cadmium: NMT 0.5 µg/g
Lead: NMT 5 µg/g
Mercury: NMT 0.2 µg/g

16. SPECIFIC TESTS
Botanic characteristics
Macroscopic: Banaba leaves vary in shape, including lanceolate, oblong-lanceolate, oblong, and elliptic ovate. They are up to
34 cm long and 11 cm wide; olive green to yellowish brown; entirely or slightly wavy at the margins; base acute; apex acute to
acuminate; leathery in texture; and petiolate with petioles up to 1 cm long.
Microscopic
Transverse section of the midrib: A layer of upper epidermis composed of rectangular to round cells covered with thin
cuticle; a few layers of collenchyma cells; numerous layers of parenchyma cells, some containing cluster crystals of calcium
oxalate, with large intercellular spaces; groups of lignified fiber bundles; and secretory canals scattered in the parenchyma
zone.
QUANTITATIVE TESTS
• FOREIGN ORGANIC MATTER: NMT 2.0%
• LOSS ON DRYING: NMT 10%
• TOTALASH: NMT 7.0%,
• ALCOHOL-SOLUBLE EXTRACTIVES: NMT 10.0%
• ACID-INSOLUBLE ASH: NMT 2%
• WATER-SOLUBLE EXTRACTIVES: NLT 18.0%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers, protected from light and moisture, and store at room
temperature.
• LABELING: The label states the Latin binomial and, following the official name, the part(s) of the plant contained in the
article.

17. American Herbal Pharmacopoeia
• 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 most frequently used in the United States.
• 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 monographs are combined monographs , the include much of the standard definition
and analytical information found in conventional pharmacopoeial monographs on standards,
therapeutic and clinical information.

18. A.H.P. MONOGRAPH FORMAT:
Title
Botanical Nomenclature
 Botanical Family
Definition
Identification
• Botanical identification: stem, leaf,
inflorescence.
 Macroscopic Identification
• Shape
• Colour
• Aroma
• Taste
 Microscopic Identification
 Constituents
 Analytical methods
• Assay Procedure
 Quantitative Tests
• Foreign organic matter
• Ethanol-soluble extractive
• Water-soluble extractive
• Ash value
• Acid-insoluble value
• Heavy metals
• Microbial contamination
• Loss on drying etc.
 Uses

19. E.g. Valerian root:
Botanical Nomenclature: Valeriana officinalis
Botanical Family: valerianaceae
Definition: valerian consist of the fragments or whole fresh or dried rhizomes, roots, amd stolons of
valeriana officinalis
Identification:
Botanical identification:
• Stem: solitary, hollow, 15-150 cm.
• Leaf: basal and cauline, opposite, oddly once pinnately lobed, lobes 11-21 lanceolate, entire or
dentate, basal leaves petiolate, cauline leaves subsessile to clasping
• Inflorescence: compound cyme, terminal or axillary, many pale pink to white, strongly scented
flowers.

20. Macroscopic identification:
• Shape: Rhizome is up to 50mm long and up to 300mm in diameter, obconical to cylindrical, with an
elongated or compressed base
• Colour: It has a yellowish- brown to dark exterior with a circular stem and leaf scars.
• Aroma: A very faint characteristic, valeric acid like aroma.
• Taste: mildly sweet and camphoraceous with a slightly bitter and spicy after taste
Microscopic identification:
• Starch grains are numerous, up to 20 micro meters in diameter, mainly 2-4 compound with cleft or
radiate hilum, packed into parenchymatous cells of cortex.
• Sclerites from rhizome are small with thick walls, narrow branched lumen, and numerous pits.
• Piliferous layer shows cicatrices or occasionally attached unicellular root hair and associated
hypodermis of elongated cells.
Constituents:
• These include the essential oil and its sesquiterpenoids (valerianic acid), epoxy iridoid esters
(valepotriates) and their decomposition products such as baldrinal and homobaldrinal, amino acids
( arginine, GABA, glutamine, tyrosine), and alkaloids.
• Valerian also possesses small amounts of phenolic acid and flavonoids, valerosidatum, cholinergic
acid, caffeic acid, choline, beta–sitosterol, fatty acid, and various minerals.

21. Analytical methods:
1. Assay of volatile oils
2. TLC, HPTLC
3. HPLC
Column : C-18, 5 micro meters, 4.6 250 mm/
Mobile phase : Methanol : 0.5%phosphoric acid (80 : 20).
Flow rate : 1.5 mL/min.
Detection : 225 nm.
Injection volume: 20 micro lit.
Run time : 15 min.
Elution order : Hydroxy valerenic acid, acetoxy valerenic acid, valerenal.
Qualitative Standards:
• Foreign organic matter: NMT 5% stem bases,
NMT 2% other foreign matter.
• Total ash : NMT 12%
• Acid insoluble ash : NMT 5%
• Loss pf moisture on drying: NMT 12%
• Extractable matter : NMT 20% The residue should weigh NLT 0.1g
• Microbial contamination: Negative for salmonella species, E coli, and staphylococcus aureus.

22. Uses:
• Insomnia
• Anxiety
• Depression
• Menstrual disorders
• Epilepsy
• Attention-deficit hyperactivity disorder(ADHD)
• Chronic fatigue syndrome
• Muscle and joint pain
• Mild tremors

23. British Pharmacopoeia
• First edition of BP was published in 1864.
• It consist of two sections
• Part I:- Materia Medica & Part II:- Preparation & compounds.
• Second edition of BP was published in 1867.
• Third and 4th edition was published in the year 1885 and 1898 respectively.
• Since 1948, which is seventh edition of B.P. the new edition of British Pharmacopoeia is published
at intervals of five years i.e. 1948, 1953, 1958, 1963, 1968, 1973. After 1973 the new edition was
published in 1980 and then in 1988, 1993, 1998, 2003, 2008. After 2008 the new edition was
published every year.
• In BP 2007 monographs has been introduced for material specifically used in preparation of
Traditional Chinese medicines.
• BP 2008 contains approximately 3100 monographs. It has been made effective from 1st January
2008.

24. B.P. MONOGRAPH FORMAT:
Title
Botanical Nomenclature
 Family
 Chemical constituents
 Macroscopic Identification
 Microscopic Identification
 Identification tests
 Analytical/ Analytical methods
• Assay Procedure
 Quantitative Tests
• Foreign organic matter
• Ethanol-soluble extractive
• Water-soluble extractive
• Ash value
• Acid-insoluble value
• Heavy metals
• Microbial contamination
• Loss on drying etc.
 Uses

25. E.g. Aloe
Botanical nomenclature: Aloe Barbadensis
Family : Liliaceae
Chemical Constituents :
Major constituents includes:
• Glycosides, anthracene derivatives, hydroxy anthraquinone derivatives, barbaloin, a mixture of
aloin A&B, The Diastereoisomeric 10-c glycosides of aloe-emodin anthrone and 7-
hydroxyaloin isomers.
Minor constituents includes:
• Aloe- emodine, chrysophanol, chromone derivatives, aloresin B (Up to 30%) with its p-
coumaryl derivatives aloeresins A&C and the aglycone aloesone.
Macroscopic identification:
• Leaves: it has thick leaves that grow in a rosette shape
• The parenchyma of leaves contain large quantities of pulp
• The fresh leaves with serrated edges that arise from a central base and grown to nearly 30-50
cm long have 10 cm width at the base.

26. Microscopic identification:
Leaves are composed of three layers:
• An inner clear gel: 99% water and rest is made of glucomannans, amino acids, lipids, sterols
and vitamins.
• The middle layer of latex: bitter yellow sap and contains anthraquinone and glycosides.
• The outer thick layer: 15-20 cells called as rind which has protective function and synthesizes
carbohydrates and proteins.
Identity tests:
• Mis 0.5g with 50ml water , boil until nearly dissolved, cool, add 0.5gm pf kieselguhr and filter.
• Heat 5ml of the filtrate with 0.2g of borax until dissolved, add a few drops of solution to a test
tube nearly filled with water, a green fluorescence is produced.
Assay/Analytical methods( from extracts):
1. Ascorbic acid estimation by HPLC method:
HPLC system : Shimatzu 2010 CHT
HPLC with uv detector : 254nm
Column : C-18
Mobile phase : 5% methanol in 0.01 M KH2PO4
Flow rate : 1ml/min
Retention time : 2.60 min
Standard : Ascorbic acid

27. 2. Aloin estimation by gravimetry method
3. Total phenolics by spectroscopic method
Qualitative tests:
• Total ash : NMT2%
• Water soluble extracts : NMT50%
• Alcohol insoluble extracts : NMT10%
• Moisture : NMT12%
• Pesticide residue : Aldrin and dieldrin is NMT 0.05mg/Kg
• Heavy metals : lead and cadmium are NMT 10&0.3mh/Kg
• Microbiological : Aerobic bac : NMT 107/gm
Fungi : NMT 105/gm
E- coli : NMT 102/gm
Uses:
• Immunomodolatory
• Wound healing
• Anticancer
• Angiogenic
• Anti viral
• Analgesis
• anti inflammatory
• hypotensice
• Prevents aging of skin

28. Comparative study: + + = present
___ = absent

29. References:
1. Indian pharmacopeia 2007 volume -3
2. USP-2021-USP-44-nf-39
3. https://www.slideshare.net/vkvikramvarma/monographs-pharmacopoeia-ppt-210454277
4. https://www.slideshare.net/RIPERAutonomus/monographs-of-herbal-drugs
5. https://www.slideshare.net/RIPERAutonomus/monographs-of-herbal-drugs-study-in-british-herbal-pharmacopoeia-and-american-herbal-
pharmacopoeia
6. https://www.slideshare.net/AmolPatil45/pharmacopoeias
7. https://www.pharmtech.com/view/brief-history-pharmacopoeias-global-perspective-1
8. https://www.booksofmedical.com/2022/05/usp-2021-usp-44-nf-39-pdf-free-download.html
9. https://online.uspnf.com/uspnf/document/1_GUID-8E8EA70F-3323-41B8-A509-706F245B4C7E_2_en-US
10. https://herbal-ahp.org/online-ordering-valerian-
root/#:~:text=Valerian%20(Valeriana%20officinalis)%20has%20been,with%20the%20compound%20valerenic%20acid.
11. https://www.webofpharma.com/2021/02/british-pharmacopoeia-2020-bp-2020.html
12. https://www.booksofmedical.com/2022/05/british-pharmacopoeia-2020-pdf-free.html