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A Comprehensive Review of Quantifications, Profiling, and Regulations of Pharmaceutical Impurities

In the past few decades impurity profiling has continuously gained the attention of regulatory bodies due to the rise in the number of drugs frequently entering the market. International regulatory agencies like ICH, FDA, Canadian Drug and Health Agency emphasize carrying out impurity profiling of drugs in strict compliance with the regulatory guidelines that have been laid down intending to ensure production of high quality and safe pharmaceutical drugs to serve mankind. Simple impurities can be easily evaluated by conventionally available methods whereas impurities present within complex matrix structure pose significant challenges to the analyst and require a more sophisticated approach. The work has been carried out with great efforts to make the study possible distinctively and comprehensively.