Simultaneous determination of low molecular weight nitrosamines in pharmaceutical products by fast gas chromatography mass spectrometry.

Control of N-nitrosamines has been in the focus of health authorities in recent years because many of these compounds are probable human carcinogens. In July 2018 the U.S.

Determination of potentially genotoxic impurities in crotamiton active pharmaceutical ingredient by gas chromatography.

In the recent years control of potentially genotoxic impurities have an increasing importance in the analysis of active pharmaceutical ingredients. Guidelines of different regulatory bodies specify very low limits for these impurities, in many cases the analytical development is challenging to comply with the requirements. In this paper potential genotoxic impurities of Crotamiton drug substance are investigated, a simple and robust gas chromatographic method is developed for the determination of genotoxic impurities in Crotamiton drug substance.