Since the discovery of the Nitrosamine impurity, N-Nitrosodimethylamine (NDMA), as a human carcinogen in mid-2018, the USFDA has been investigating and conducting a detailed analysis of the impurities in drug products and APIs. As the concept of Nitrosamine impurities extends beyond the drug supply in the US, other Regulatory Authorities also partnered with the USFDA to share information and effective analytical methods in identifying various Nitrosamines and providing rapid solutions for the safety and quality of the drug supply. This white paper provides information on the formation and identification of acceptable levels of the impurities for different Nitrosamine compounds, necessary Regulatory actions to be taken if the risk of presence is identified, methods to mitigate the risk of formation and recommendations to the manufacturers.
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