Advanced Technologies For Detection, Characterization and Identification of Pharmaceutical Impurities

Abstract: Pharmaceutical impurities are the unwanted chemicals that remain with the active pharmaceutical ingredients, or develop during synthesis or formulation. It is important critically to have control on these impurities. For the purpose, International Conference on Harmonization (ICH) has published some guidelines. Also, different pharmacopoeias such as United States Pharmacopoeia (USP), British Pharmacopoeia (BP) and other regulatory bodies are slowly incorporating limits to allowable level of impurities. In the following review, a description of various sources of impurities with reference to ICH guidelines along with different methods used for their analysis are covered. The spectral (ultraviolet spectroscopy, nuclear magnetic resonance, mass spectrometry), chromatographic (liquid chromatography, gas chromatography, high performance liquid chromatography) and electrophoretic (capillary electrophoresis) methods are discussed in general. The methods are with single technology and combined form for the detection, characterization and identification of impurities.

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