Nitrosamine Impurity: A Regulatory Perspective

 

The Regulatory agency announced that Nitrosamine impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are said to be present in generic drug substances and drug product, especially in angiotensin II receptor blockers (ARBs) and belong to a family of analog compounds referred to as the sartans. Further FDA and EMA investigation also led to the detection of these Nitrosamine impurities in Pioglitazone and the low level of NDMA impurity found in Metformin.

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