Various approaches for impurity profiling of pharmaceuticals -An overview

Abstract

Tremendous attention is given for the impurity profiling of pharmaceutical products in present time. Impurities can endanger the human health by affecting quality, safety and efficacy of the product. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Due to the noticeable impact of impurities on quality of pharmaceuticals, impurity control in pharmaceutical products is a primary goal of drug development. To assure the quality of drugs, impurities must be monitored carefully. Stringent international regulatory requirements have been in place for several years as outlined in USFDA, Canadian Drug and Health Agency, International Conference on Harmonization. In this review, a description of different types of impurities and their origin in relation to ICH guidelines are presented. The article further throws light on to different methodological aspects of impurity profiling such as NMR, MS, TLC, HPLC, HPTLC, GC, CE and other hyphenated techniques like, LC-MS, GC-MS,LC-NMR, CE-MS and ICP-MS which are routinely used for monitoring impurities.