G. Maggi Stella*, K. Geetha, A. Ajitha, V. Uma Maheswara Rao


Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. According to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guideline 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’. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, and HPTLC etc. The most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LCNMR- MS, GC-MS, and LC-MS.

Keywords: LC-MS-MS, LC-NMR, LCNMR- MS, GC-MS, and LC-MS.

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