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Ganesh S. Todkar* and Dr. Uday A. Deokate


A change in human health was brought about by the invention of pharmaceuticals. These pharmaceuticals can fulfil their function only if they are free of impurities and are given in a sufficient quantity.[1] Impurity profiling requires the recognition, structural elucidation and quantitative determination of the bulk drug materials and pharmaceutical formulations of impurities and degradation items.[2] Isolation, detection and quantification of impurities enable us in different ways to achieve a pure material with less toxicity and protection in drug therapy.[3] Impurities are a critical issue for the pharmaceutical industry at present. Guidelines on the control of impurities were formulated by the International Harmonization Conference (ICH). With specific examples, this review describes different types and origins of impurities and degradation routes.[4] In this analysis, an overview of the various forms and sources of impurities i.e. organic inorganic impurities, residual solvents is provided in relation to the ICH guidelines and the routes of degradation, including detailed examples.[5] A variety of chromatographic and spectroscopic methods are used to detect impurities, either individually or in conjunction with other techniques.[6] This review provides useful information on impurities, their classification and the origins of impurities, and discusses various isolation (Liquid-solid methods of extraction, Liquid-liquid methods of extraction Column chromatography, Flash chromatography, TLC,GC, HPLC, etc.) and characterization methods (Nuclear Magnetic Resonance (NMR), IR, Mass Spectroscopy (MS), LC-MS), analytical techniques for the determination of impurities, and the identification of impurities.[3]

Keywords: Impurities, ICH Guidelines, Classification of Impurities, Sources of impurities, Methods of Isolation, Methods of Characterization.

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