A CONCEPT ON SOURCES OF IMPURITIES

The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon ageing of both API and formulation. The presence of these unwanted chemicals even in trace amounts may influence the efficacy and safety of pharmaceutical products. The control of impurities is currently a critical issue to the pharmaceutical industry. The 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, formulation, efficacy, degradation.