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S. G. Uttarwar*et al. /International Journal Of Pharmacy&Technologylabeled medicinal product that contain active ingredients, aerial or underground parts of the plant or other plant materialor combinations 2 .In all traditional systems of medicine, the quality control aspect has been considered from its inspection itself byPractitioners for effective and safe use. However, modern concept require necessary changes in their access by that wayconcrete method of quality control in terms development of modern methodologies. Hence quality assurance is hurl areafor the evaluation of botanicals and herbal formulations so utmost chore is to evolve such parameter by which thepresence of the entire ingredients can be identified. For standardization of herbal drugs various chromatographicprofiles, spectrophotometric methods and evaluation of physicochemical properties can be tried to evolve pattern foridentifying the presence of different ingredient 3 .Stream Regulations for Standardization of Crude DrugsInternationally various pharmacopoeias have provided monographs stating parameters and standards of many herbs andherbal products to maintain their quality in their respective nations. British Herbal Pharmacopoeia British Herbal Compendium Chinese Herbal Pharmacopoeia United States Herbal Pharmacopoeia Japanese Standards for Herbal Medicine The Ayurvedic Pharmacopoeia of India (API)Government of India besides has come out with Ayurvedic Pharmacopoeia, which recommends basic qualityparameters for eighty common Ayurvedic herbal drugs.Standardization and Quality Control Parameters for Evaluation of Herbal Crude Drugs 4Standardization accounting to WHO is the process involving the physicochemical evaluation of crude drug covering theaspects, as selection and handling of crude material, safety, efficacy and stability assessment of finished product,documentation of safety and risk based on experience, provision of product information to consumer and productpromotion.IJPT | July-2013 | Vol. 5 | Issue No.2 | 2509-2519 Page 2510
S. G. Uttarwar*et al. /International Journal Of Pharmacy&TechnologyThe quality and purity required in a drug are achieved by standards given in the official work of reference. To establishthe identity and quality of the drug, several methods may be considered 5,6-8 .These are enumerated below,• Macroscopic Examination: In case of whole drug, the macroscopic and sensory characters are sufficient foridentification of right variety and search of adulterants.• Microscopic Examination: These are valuable both for powders and ungrounded drugs for identification ofright variety and search of adulterants.• Solubility: The solubility, especially exceptional behavior towards solvent, is useful in examination of many oilsand oleo-resins.• Physical constants: Physical constants such as specific gravity, optical rotation, viscosity and refractive indexare especially valuable for the evaluation of fats, oleoresins, balsams and similar substances.• Foreign Organic Matter: Remove of matter other than source plant to get the drug in pure form.• Ash Values: It is criteria to judge the identity and purity of crude drug – Total ash, sulfated ash, water solubleash and acid insoluble ash etc.• Extractive Values: These are indicating the approximate measure of chemical constituents of crude drug.• Moisture Content: To check moisture content helps prevent degradation of product.• Crude Fiber: To determine excessive woody material Criteria for judging purity.• Chromatographic Examination: Include identification of crude drug based on use of major chemicalconstituent as marker.• Qualitative Chemical Evaluation: Covers criteria for identification and characterization of crude drug withrespect to phytochemical Constituents.• Quantitative Chemical Evaluation: Covers criteria to estimate the amount of active constituents.• Volatile oils: its cover the measurement of the volatile content of the plant.• Bitterness value: The bitter properties of plant material are determined by comparing the threshold bitterconcentration of an extract of the materials with that of a dilute solution of quinine hydrochloride R.IJPT | July-2013 | Vol. 5 | Issue No.2 | 2509-2519 Page 2511
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