Abstract

SHORT REVIEW ON GENOTOXIC IMPURITIES IN SARTANS

Amari Mohamed Khamis, Charos Tuychi qizi Omonova and Benson Peter Mugaka*

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Abstract

The nitrosodimethylamine (NDMA), a confirmed genotoxic impurity, was first reported in valsartan active pharmaceutical ingredient (API) by the European Medicines Agency (EMA) in 2018. Manufacturers performed voluntary recalls followed by investigations of contamination by health regulatory authorities. In this review, we discussed potential sources, mechanism of the formation of NDMA, and other nitrosamines impurities in valsartan, losartan, irbesartan, candesartan, and olmesartan. Additionally, we summarized currently available validated analytical techniques for controlling these impurities as suggested by regulatory authorities. An overview of measurements by regulatory authorities was mentioned, and we also outlined suggestions for viable solutions to avoid future crises.

Keywords: Nitrosamine, ARBs, genotoxic impurities, valsartan recalls.