Since the FDA’s discovery of nitrosamines impurities, which led to the voluntary recall of valsartan in 2018, the pharmaceutical industry has undertaken a thorough investigation of this class of compounds to ensure patient safety. Since nitrosamines are a class of organic compounds identified as probable human carcinogens, the potential presence of these compounds in drug products is of concern. The FDA is working with regulatory agencies to set acceptable limits around the world and to remove drugs with higher than acceptable nitrosamine levels from the US market. In addition, the FDA is taking proactive measures to ensure that future drug products are free from unsafe levels of nitrosamines.1,2 This requires the evaluation of manufacturing processes and the development and implementation of validated test methods capable of achieving the necessary sensitivity limits for monitoring nitrosamines in existing and new drug products.
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