Evaluation of the risk of nitrosamine impurities

White papers - 6 May 2020

BlueReg Group White papers Evaluation of the risk of nitrosamine impurities

Evaluation of the risk of nitrosamine impurities

“During the summer 2018, authorities become aware of the presence of some nitrosamines in API – (Valsartan – presence of N- nitrosodimethylamine (NDMA) – other sartans – presence of N-nitrosodiethylamine NDEA).   These nitrosamines were already known as probable carcinogenic compounds but their presence in the sartans was not then identified.”

 

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