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Dr. K. Mangamma*, B.T. Anil Kumar, Yenduri Leela Priyanka and Akkala Sai Veneela


Impurity is any substance coexisting with the original drug such as starting material or intermediates or that is formed due to any side reaction. Impurity profiling includes identification, structural elucidation and quantification of impurities and degradation products and bulk drug materials and pharmaceutical formulations. The presence of impurities influence the safety and efficacy of pharmaceutical product. So the profiling of impurity is very crucial. Some impurities are unavoidable and will be present in trace amounts hence ICH guidelines and policies establishes the specification limits, evaluation and control of impurities. Validation of analytical process is performed for the identification of impurity to establish a impurity profile of any drug substance. This review focuses on sources of impurities, its classification, various analytical techniques for the identification and quantification of impurities.

Keywords: Impurities, Impurity profiling, Active pharmaceutical ingredient, Efficacy, Evaluation, Validation.

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