Evaluation of the risk of nitrosamine impurities
White papers - 6 May 2020
“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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