Evaluation of the risk of nitrosamine impurities

Communication Marketing
Regulatory affairs Pharmaceutical industry
Regulatory affairs Pharmaceutical industry
May 6, 2020
  • Drug Development
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“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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