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 may influence the efficacy and safety of pharmaceutical product. The current practice of characterization and control of impurities in pharmaceutical substances and products are reviewed with emphasis on issues specific to the active pharmaceutical ingredient and pharmaceutical formulations. The international conference on harmonization (ICH) has formulated a workable guideline regarding the control of impurities in pharmaceutical drug substance as well as formulations. Thus enlightening the need of impurity profiling in pharmaceutical research this review focuses on various tools available for optimization and characterization of impurities present in the pharmaceuticals.
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