According to the International Conference on Harmonization guidelines on impurities in new drug substances, an impurity is defined as any component of the new drug substance that is not the chemical entity defined as the new drug substance. Impurities can be formed during drug synthesis, manufacturing and/or storage. Impurity profiling helps in detection, identification and quantification of various types of impurities as well as residual solvents in bulk drugs and in pharmaceutical formulations. There are different chromatographic and related separation methods, spectroscopic and hyphenated techniques for detecting and characterizing impurities. The advent of hyphenated techniques has not only separation but structural identification of impurities as well. Among all hyphenated techniques the most exploited techniques for impurity profiling of drug are LC-MS-MS, LC-NMR, LC-NMR-MS, GC-MS AND LC-MS. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agencies are emphasizing on the purity requirements and on identification of impurities in active pharmaceutical ingredients as presence of impurities even in small amounts may influence the efficacy and safety of the pharmaceutical products. Thus enlightening the need of impurity profiling of drug substances in pharmaceutical research, this review focuses on characterisation of the sources of impurities and analytical methods for identification as well as quantification of impurities present in the pharmaceuticals. This is the best way to characterize the quality and stability of bulk and pharmaceutical formulations.
Loading....