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Quality Control & Standardization
Of Herbals
WHO Guidelines For Quality Control Of
Herbal Drugs
By
Kaushal Kumar
Tabel Of Contents
01 02 03 04
Introduction Monograph Parameter Type
Quality control of herbal medicines aims
to ensure their consistency, safety and
efficacy.
Chemical fingerprinting has been
demonstrated to be a powerful technique
for the quality control of herbal medicines.
Introduction
For the purpose of quality control of herbal drugs, the World Health Organization (WHO)
has prepared the guidelines. The objective of the guidelines involves general test methods
and also the general limits for contaminants in herbal drugs. A typical monograph for herbal
drugs as per WHO Guidelines is as follows:
Monograph for Herbal Drugs as per WHO Guidelines
Introduction
Monograph Title Parameters Types
Botanical
Sensory Evaluation Visual/ Macroscopy/ Touch/
Taste/ Odour/ Size/ Colour
Foreign Matter Foreign plants, animals, minerals
(soil, stones, sand and dust)
Microscopy Histological observation,detection,
measurement of specimens, etc.
Introduction
Monograph Title Parameters Types
Physicochemical
TLC Ascending technique, horizontal
technique, etc.
Ash Total, acid insoluble, water-soluble
Microscopy Histological observation,detection,
measurement of specimens, etc.
Extractable matter Hot water, cold water and ethanol
Water content
and volatile
Matter
LOD, Azeotropic
Volatile oils By steam distillation
Monograph Title Parameters Types
Pharmacological
Bitterness value Units Ex- To the bitterness of
standard solution of Quinine
hydrochloride
Haemolytic Activity On Ox blood by comparison
with standard saponin
Astringency Fraction (Tannins) that binds to
standard hide powder
Swelling Index In water
Foaming Index Foam height produced by 1 gm
material under specified
conditions
Monograph
Monograph
Monograph Title Parameters Types
Toxicological
Pesticide residue Total organic chloride and total
organic
Phosphorus
Arsenic Stain produced on HgBr2
paper in comparison to
standard stain
Heavy metals Cadmium and Lead
Microbial Contamination
Aerobic count pathogen Enterobacteriaceae -
Escherichia coli, Salmonella,
Staphylococcus,
Pseudomonas
Aflatoxins TLC using standard Aflatoxins
(B;, Bz, G;, G2) mixture
Monograph
Monograph Title Parameters Types
Radioactive
contamination
Microbial growth in herbals can be avoided by irradiation.
Nature
and the intensity of irradiation depend on the source. The
radioactivity of the plant samples should be checked
according to
the guidelines of the International Atomic Energy Agency
(IAEA),
Vienna, Austria.
THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666

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who guidelines for herbal drugs

  • 1. Quality Control & Standardization Of Herbals WHO Guidelines For Quality Control Of Herbal Drugs By Kaushal Kumar
  • 2. Tabel Of Contents 01 02 03 04 Introduction Monograph Parameter Type
  • 3. Quality control of herbal medicines aims to ensure their consistency, safety and efficacy. Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines. Introduction
  • 4. For the purpose of quality control of herbal drugs, the World Health Organization (WHO) has prepared the guidelines. The objective of the guidelines involves general test methods and also the general limits for contaminants in herbal drugs. A typical monograph for herbal drugs as per WHO Guidelines is as follows: Monograph for Herbal Drugs as per WHO Guidelines Introduction Monograph Title Parameters Types Botanical Sensory Evaluation Visual/ Macroscopy/ Touch/ Taste/ Odour/ Size/ Colour Foreign Matter Foreign plants, animals, minerals (soil, stones, sand and dust) Microscopy Histological observation,detection, measurement of specimens, etc.
  • 5. Introduction Monograph Title Parameters Types Physicochemical TLC Ascending technique, horizontal technique, etc. Ash Total, acid insoluble, water-soluble Microscopy Histological observation,detection, measurement of specimens, etc. Extractable matter Hot water, cold water and ethanol Water content and volatile Matter LOD, Azeotropic Volatile oils By steam distillation
  • 6. Monograph Title Parameters Types Pharmacological Bitterness value Units Ex- To the bitterness of standard solution of Quinine hydrochloride Haemolytic Activity On Ox blood by comparison with standard saponin Astringency Fraction (Tannins) that binds to standard hide powder Swelling Index In water Foaming Index Foam height produced by 1 gm material under specified conditions Monograph
  • 7. Monograph Monograph Title Parameters Types Toxicological Pesticide residue Total organic chloride and total organic Phosphorus Arsenic Stain produced on HgBr2 paper in comparison to standard stain Heavy metals Cadmium and Lead Microbial Contamination Aerobic count pathogen Enterobacteriaceae - Escherichia coli, Salmonella, Staphylococcus, Pseudomonas Aflatoxins TLC using standard Aflatoxins (B;, Bz, G;, G2) mixture
  • 8. Monograph Monograph Title Parameters Types Radioactive contamination Microbial growth in herbals can be avoided by irradiation. Nature and the intensity of irradiation depend on the source. The radioactivity of the plant samples should be checked according to the guidelines of the International Atomic Energy Agency (IAEA), Vienna, Austria.
  • 9. THANKS! Do you have any questions? easyconceptkaushal@gmail.com +91 9546688666