Nitrosamine impurities in APIs: A Comprehensive Review (Review Article)

Author(s): Sumit S. Chourasiya and Kamlesh J. Ranbhan

Abstract: Nitrosamine impurities are a class of substances formed from the reaction of a nitroso compound and secondary or tertiary amines. This class of compounds have received attention in the recent past after the revelation of their genotoxic profile. In this context, many batches of API (Active Pharmaceutical Ingredients) supplied to the market were screened for the presence of nitrosamine impurities and recalled due to the presence of genotoxic impurities above the acceptable limit. In this review, we have discussed, the chemistry of nitrosamine impurities, their classification, a possible source for their origin, strategy to control them. A perspective of different regulatory agencies on nitrosamine impurities is also presented. A few case studies which include Valsartan and Metformin are also provided for better understanding. The advancement in analytical techniques for the detection of nitrosamine impurity is also discussed. This review will improve an understanding of pharmaceutical scientists on nitrosamine impurities in pharmaceuticals and thus will find its potential application in academia as well as in industry.

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