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PHARMACOPOEIAL STANDARDS FOR AYURVEDIC DRUGS Introduction India has Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules of 1945 for drug regulation. Also Dangerous Drug Act, 1930 and Poisons Act 1919 define drug related policies. These acts and related rules regulate export, manufacture, distribution and sale of drugs and cosmetics. Considering increase in demand, use and export of drugs from Ayurvedic and other systems included in AYUSH; Government of India has specified the rules and notifications related manufacturing, standardization and other aspects of drug usage. Ayurvedic, Unani and Homoeopathic Pharmacopoeias published by the Govt. of India have prescribed various standards to be followed for ISM & Homoeopathic drugs. In 2002 Govt. of India published Good Laboratory Practices (GLP) guidelines to guide the drug analysts in maintaining high scientific and professional standards for ensuring only drugs of the highest quality are produced and marketed. In 2003, government issued notification of Good Manufacturing Practices (GMP) to ensure authentic, contamination free quality raw material, manufacturing process and product with desired quality standards. Guidelines for Quality Control Standards for quality control are based on pharmacognostic, physicochemical, phytochemical and biological parameters. General process and parameters employed in present standardization of herbal drugs is described below. 1. Sample collection as per suitable sampling plan 2. Identification 2.1. Organoleptic characterization 2.2. Specific chemical tests (wherever available) 2.3. Microscopic analysis 2.4. Powder microscopy 2.5. TLC comparison with authentic reference standard 3. Physico-chemical Analysis 3.1. Moisture content 3.2. Volatile / fixed oil determination 3.3. Ash value (total, sulphated, acid insoluble, ash etc) 3.4. pH of 5 % w/v suspension 3.5. Extractive values (with various solvents like alcohol, water etc) 3.6. Identity tests (like T.L.C., HPLC etc) 4. Phytochemical analysis 4.1. Quantification of bioactive/marker compounds 4.2. Quantification of characteristic category compounds (like flavanoids, alkaloids, terpenoids, glycosides etc)
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5. Microbiological analysis 5.1. Total viable aerobic court 5.2. Total enterobacteriaceae 5.3. Total fungal count 5.4. Test of specific pathogens (S. aurus, E. coli, P. aeruginosa etc) 6. Residual analysis 6.1. Foreign matter 6.2. Heavy metals residues (Pb, Cd, Hg, As etc) 6.3. Pesticide residues (organochloro, organophosperous etc) 6.4. Mycotoxin residues (Aflatoxins B1, b2, G1, G2, Sterigatocistin, Ochratoxin etc) 6.5. Radioactive residues 6.6. Solvent residues (volatile organic impurities) 7. Biological activities 7.1. Dose response curve 7.2. Dose and duration 7.3. Limits of desired bioactivity 8. Toxicity or Safety profile 8.1. Acute toxicity (including LD 50 value) 8.2. Sub-acute toxicity 9. Other documentation 9.1. Rasa (Taste), Veerya (Predominant action), Vipaka (Metabolic action) 9.2. Guna (Properties), Karma (Pharmacological action) 9.3. Authentic/Textual References 9.4. Important Formulations, Dose etc. 9.5. Therapeutic Uses 10. Processing specifications 10.1. Details of manufacturing process 10.2. Bhaavanaa, Mardana, Put`a etc 10.3. Shelf life, storage Standards for classical dosage forms Each dosage form (Kalpanaa) has specific manufacturing process hence requires separate standards for assessment of quality and purity. Considering nature of raw materials, processing and product; each formulation type has to be screened for various parameters like contamination (e.g. microorganisms), assessment of expected level of desired ingredients (e.g. Sugar) or results of manufacturing processes (e.g. extractive value after extraction). Standards for some of the classical dosage forms are described based on compilation of various guidelines. Users are advised to go through references and follow respective norms after proper scrutiny of local guidelines and legal considerations. (e.g. Each state or province might have different act, rules also different lists of banned drugs etc.)
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Protocol of testing Kvaatha (Decoction) 1. Name of preparation: 2. Reference 3. Organoleptic Characters (Colour /Odour etc) 4. pH 5. Total solids 6. Specific Gravity 7. Test for heavy/toxic metals a. Lead b. Cadmium c. Test for Arsenic d. Mercury 8. Microbial Contamination a. Total viable aerobic count b. Enterobacterciaceae c. Total fungal count 9. Test for specific Pathogens a. E. Coli b. Salmonella Spp. c. S. aureus d. Pseudomonas aeruginosa 10. Test for Aflatoxins a. B1 b. B2 c. G1 d. G2 11. TLC/HPTLC- with marker (wherever possible) 12. Pesticide residue a. Organochlorine pesticides b. Organophosphorous pesticides c. Pyrethroids 13. Dosage 14. Shelf life a. Normal b. Accelerated Protocol of testing Avaleha (Leha and Paaka) 1. Name of preparation 2. Reference 3. Description: a. Macroscopic b. Microscopic 4. Colour 5. Odour 6. Taste 7. Consistency 8. Total sugar 9. Reducing sugar
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10. TLC/HPTLC 11. Extractive value a. Hexane voluble b. Alcohol soluble c. Water soluble 12. Fat content 13. Loss on drying at 105C 14. Total solid content 15. pH 16. Specific gravity at 25C 17. Ash value: a. Total ash value b. Acid insoluble ash c. Sulphated ash 18. Assay of main ingredients 19. Crude fibre content (in case of Prakshepa Dravya) 20. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 21. Microbial contamination. a. Total Bacterial count b. Total fungal count c. Enterobacterciaceae d. Salmonella Spp. 22. Ayurvedic specification a. Supakvam b. Tantumatatvam c. Apsumajati d. Karatvam Pidite mudra e. Gandha Varn`a Rasaodbhavam 23. Therapeutic indications 24. Dose 25. Shelf life a. Normal b. Accelerated Protocol of testing Taila / Ghrita 1. Name of preparation 2. Reference 3. Description 4. Colour (RYB value) 5. Odour 6. Rancidity 7. Coagulation point 8. Specific gravity (wt. /ml.) at room temperature 9. Refractive index at 25C
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10. 11. a. b. c. d. e. f. g. 12. 13. a. 14. 15. 16. 17. a. b.

Viscosity Specific tests Saponification value Acid value Iodine value Peroxide value (residue) Free Fatty acids Qualitative test (For particular oil) Total fatty matter Test for mineral oil (ISI method) TLC /HPTLC Profile of unsaponifiable matter Assay for main ingredients Therapeutic use Dosage Congealing point (for Ghrita only) Shelf Life study Normal Accelerated.

Protocol of testing Guggulu (Guggulu based formulations) 1. Name of preparation: 2. Reference 3. Description a. Identification b. Macroscopic c. Microscopic d. Uniformity by weight 4. pH 5. Extractives a. Alcohol soluble extract b. Water extract 6. Loss on drying on 105C 7. TLC 8. Ash value: a. Total ash b. Acid insoluble ash 9. Description: general, including colour, odour, taste etc 10. Volatile oil contents (Oleo gum resin) 11. Test for resin 12. Assay for main ingredients 13. Disintegration time 14. Metal compound contents (as per Bhasma if added) 15. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 16. Microbial contamination a. Total viable aerobic count
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b. c. 17. a. b. c. d. 18. a. b. c. d. 19. a. b. c. 20. 21. 22. a. b.

Enterobacteriaceae Total fungal count Test for specific pathogen E. coli Salmonella spp S. aureus Pseudomonas aeruginosa Test for Aflatoxins B1 B2 G1 G2 Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids Therapeutic indications Dose Shelf Life study Normal Accelerated.

Protocol of testing Bhasma 1. Name of preparation 2. Reference 3. Method of preparation a. Method of S`hodhana (purification) with reference b. Method of Bhasma formation with reference c. Types & No. of Put`a (Incunation) d. Bhavana Dravya Used (Trituration material used) 4. Description (colour & texture) 5. Particle size 6. Loss on drying 7. Acid insoluble ash 8. Water solubility. 9. Organoleptic characters: general, including colour, odour, taste etc 10. Heavy metal test a. Lead b. Cadmium c. Arsenic d. Mercury 11. Assay (of main ingredients) 12. Namburi Spot Test 13. Ayurvedic specifications a. Lusterless (Nis`hchandrikaa) b. Fineness (fine enough to enter in lines of finger - Rekhaapoorn`atva) c. Floats on water (Vaaritara) d. Smokeless (Nirdhooma) e. Tasteless (Nisvaadu)
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f. Irreversible (Apunarbhava) 14. Dose 15. Method of administration 16. Toxicity report 17. Shelf Life study a. Normal b. Accelerated. (In the final product Bhasma, metals are the compounds forms which are not toxic.) Protocol of testing Vat`i / Gut`ikaa (pills & tablets) 1. Name of preparation: 2. Reference 3. Description 4. Physical characteristics a. Colour b. Odour c. Taste d. Macroscopic characteristics e. Microscopic characteristics f. Texture g. Size 5. TLC, HPTLC profile 6. Loss on drying at 110 0 C 7. Ash value: a. Total ash b. Acid insoluble ash c. Sulphated ash 8. Study of extractives a. Alcohol soluble extracts b. Water soluble extracts 9. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 10. Microbial contamination a. Total viable aerobic count b. Enterobacteriaceae c. Total fungal count 11. Test for specific pathogen a. E. coli b. Salmonella spp c. S. aureus d. Pseudomonas aeruginosa 12. Test for Aflatoxins a. B1 b. B2 c. G1
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d. 13. a. b. c. 14. a. b. 15. 16. 17. 18. 19. 20. 21. 22. 23.

G2 Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids Shelf life study Normal Accelerated Average weight Disintegration time Hardness Friability Content uniformity Metal content Weight variation Usual dose Therapeutic indications

Protocol of testing Lauha / Man`d`oora (Preparations of iron prominence) 1. Name of preparation 2. Reference 3. Description 4. Physical characteristics a. Macroscopic characteristics b. Microscopic characteristics 5. Particle size 6. Loss on drying at 105 0 C 7. Ash value: a. Total ash b. Acid insoluble ash 8. Study of extractives a. Alcohol soluble extracts b. Water soluble extracts 9. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 10. Microbial contamination a. Total viable aerobic count b. Enterobacteriaceae c. Total fungal count 11. Test for specific pathogen a. E. coli b. Salmonella spp c. S. aureus d. Pseudomonas aeruginosa 12. Test for Aflatoxins a. B1 b. B2
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c. d. 13. 14. a. b. c. d. e. f. 15. a. b.

G1 G2 TLC, HPTLC profile Ayurvedic specifications Lusterless (Nis`hchandrikaa) Fineness (fine enough to enter in lines of finger - Rekhaapoorn`atva) Floats on water (Vaaritara) Smokeless (Nirdhooma) Tasteless (Nisvaadu) Irreversible (Apunarbhava) Shelf life study Normal Accelerated

Protocol of testing Kshaara / Lavan`a (compounds of salts) 1. Name of preparation 2. Reference 3. Description a. Colour b. Odour c. Taste d. Texture 4. Identification: chemical test applicable to identify major 5. Loss on drying at 105 0 C 6. pH 7. Acid insoluble ash 8. Solubility in water 9. Assay for specific salt 10. Therapeutic indications 11. Dose and method of administration Protocol of testing Choorn`a (powders) 1. Name of preparation 2. Reference 3. Description 4. Particle size 5. Identification: a. Macroscopic b. Microscopic c. Phyto-chemical tests assay wherever possible d. TLC 6. Study of extractives a. Hexane soluble extracts b. Alcohol soluble extracts c. Water soluble extracts 7. pH 8. Loss on drying at 105 degree C. 9. Ash value
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a. b. 10. a. b. c. d. 11. a. b. c. 12. a. b. c. d. 13. a. b. c. d. 14. 15. a. b. c. 16. 17. 18. a. b.

Total ash Acid insoluble ash Test for heavy metals Lead Cadmium Arsenic Mercury Microbial contamination Total viable aerobic count Enterobacteriaceae Total fungal count Test for specific pathogen E. coli Salmonella spp S. aureus Pseudomonas aeruginosa Test for Aflatoxins B1 B2 G1 G2 TLC / HPTLC with marker Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids Therapeutic indication (Ref. to AFI) Method of application to be specified. Shelf life study Normal Accelerated

Protocol of testing Aasava / Aristha 1. Name of preparation: 2. Reference 2. Description a. Macroscopic b. Microscopic 3. Colour (RYB Value) 4. Odour 5. pH 6. Specific Gravity at 25 C 7. Total Solids 8. Alcohol Contents 9. Non reducing sugars 10. Reducing sugars 11. TLC/HPTLC 12. Test for methanol 13. Total acidity
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14. Safety profile 15. Test for heavy metals Lead Cadmium Arsenic Mercury 16. Dosage 17. Shelf life study a. Normal b. Accelerated Protocol of testing Arka 1. Name of preparation: 2. Reference 3. Description 4. Colour 5. Odour 6. pH 7. Volatile Matter 8. Specific Gravity at 25 C 9. Clarity Test /Suspended Particles 10. Sterility Test 11. Assay 12. TLC /HPTLC/GLC 13. Dosage 14. Shelf Life study a. Normal b. Accelerated 15. Microbial contamination Protocol of testing Parpat`ee 1. Name of preparation 2. Reference 3. Colour 4. Touch 5. Particle size 6. Lusterless (Nis`hchandrikaa) 7. Loss on drying at 105 C 8. Assay of Mercury and Sulphur 9. Dosage 10. Shelf Life study a. Normal b. Accelerated Protocol of testing Kupipakva Rasaayana (Mercurial compounds) 1. Name of preparation 2. Reference 3. Organoleptic characters (Colour, taste etc) 4. Ash value:
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a. Total ash b. Acid insoluble ash 5. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 6. Microbial contamination a. Total viable aerobic count b. Enterobacteriaceae c. Total fungal count 7. Test for specific pathogen a. E. coli b. Salmonella spp c. S. aureus d. Pseudomonas aeruginosa 8. Test for Aflatoxins a. B1 b. B2 c. G1 d. G2 9. TLC / HPTLC with marker 10. Dosage 11. Shelf Life study a. Normal b. Accelerated Protocol of testing Khalvi Rasaayana (Organo mineral / mineral preparations) 1. Name of preparation 2. Reference 3. Organoleptic characters (Colour, taste etc) 4. Ash value: a. Total ash b. Acid insoluble ash 5. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 6. Nambudri Spot Test 7. Dosage 8. Shelf Life study a. Normal b. Accelerated

Standards for other herbal dosage forms Minimum assessment for other herbal dosage forms

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Suspension 1. Appearance 2. Sedimentation volume 3. Redispersibility 4. Particle size distribution Emulsions 1. Appearance 2. Sedimentation volume 3. Redispersibility 4. Particle size distribution 5. Microbial count 6. Coalescence (photomicrograph) Capsules (hard / soft) 1. Weight variation 2. Content uniformity 3. Disintegration time Ointments 1. Appearance 2. Colour 3. Homogeneity 4. pH 5. Metal particles Abbreviations: AFI = Ayurvedic Formulary of India API = Ayurvedic Pharmacopoeia of India GLP = Good Laboratory Practices GMP = Good Manufacturing Practices TLC = Thin Layer Chromatography HPLC = High Performance Liquid Chromatography AYUSH = Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, Ministry of Health & Family Welfare, Govt. of India References: 1. Anonymous, (2001) The Ayurvedic Pharmacopoeia of India (Part-1, Vol.3, 1st Edition), Govt. of India, Ministry of Health and Family Welfare, Dept of AYUSH. 2. Anonymous (2001) The Ayurvedic Formulary of India (Part -2) 1st Edition Published by Govt. of India, Ministry of Health and Family Welfare, Dept of AYUSH. 3. Sharma S.K., (2004) Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Medicines in India, Regional Training Course on Herbal Drug Industry for Compliance to Quality Parameters New Delhi, India. 4. Mukherjee Pulok K & Verpoorte Robert (2003) GMP for Botanicals (Regulatory and Quality issues on Phyto-Medicines), Business Horizons Pharmaceutical Publishers, New Delhi.
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5. Mukherjee Pulok K (2002) 1st edition Quality control of drugs (an approach to evaluation of botanicals), Business Horizons Pharmaceutical Publishers New Delhi. 6. Current Good Laboratory Practices Guidelines document for ISM & Homoeopathic drug testing laboratories, (2002) Dept of AYUSH, MoH&FW, Govt. of India. 7. Good Manufacturing Practices notification, (2003), Dept of AYUSH, MoH&FW, Govt. of India. 8. http://indianmedicine.nic.in/html/acts/act.htm (accessed on 13 March 2006)

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