Abstract

A REVIEW ON SYNTHESIS, CHARACTERIZATION AND GENOTOXIC EVALUATION OF DRUG IMPURITIES

Shebin John* and Pramila T.

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Abstract

The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount might influence the efficacy and safety of pharmaceutical product. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities. This review outlines the description of different types and origins of impurities and degradation routes with specific examples.

Keywords: Impurities, Efficacy, Formulation.