SGS experts help to mitigate the risk of nitrosamine impurities in drug products
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Presence of NDMA, N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in a drug product (DP) is a cause for concern as these compounds are all recognised as probable human carcinogens.
Even at low levels, these genotoxic impurities pose a potentially significant threat to human health. This danger and the unexpected presence of these impurities made it clear manufacturers need to be proactive and mitigate the risk of the compounds’ presence in APIs and DPs.