Review Article Open Access

Analytical Assessment of Genotoxic Impurities in Pharmaceuticals by Gas Chromatographic Techniques

Abstract

Recently, genotoxic impurities gained attention from pharmaceutical industry and health authorities as their presence affects the safety, efficacy and quality of the drugs. Regulatory authorities like ICH, EMA, FDA has given the guidelines on identification, control, analytical methods of GTI’s (Genotoxic impurities). Hence these impurities need to be identified, isolated and analysed by different analytical methods to control the GTI’s in active pharmaceutical ingredients. Analysis of GTI’s has become a challenge to pharmaceutical industries which requires selective, sensitive and robust methods. This article provides information on sources, classification, regulatory documents of GTI’s. It also emphasises on risk characterisation, factors for better targeting of analytical methods, analytical challenges, and analytical assessment of genotoxic impurities and genotoxicity prediction. The article mainly describes different techniques of Gas chromatography by which volatile samples can be analysed.

Sultan Supriya, Anand Kumar Tengli and Akhila G

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