Nitrosamine compounds are potent genotoxic carcinogens in several non-human species and are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC).
Since June 2018, several N-nitrosamines have been detected in several batches of drug substances, initially from Sartans, but now the concern of the health agencies has been extended to all drug substances and also to drug products.
Although initially were detected N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) also by the time other N-nitrosamines were added to these two.
Heath agencies required to the pharmaceutical companies to do a risk assessment about the possible presence of such N-nitrosamines in their products and experimentally demonstrate that are not present in the case of the risk assessment anticipate their possible presence. The list of the N-nitrosamines that must be tested should be obtained from the risk assessment.
We offer all N-nitrosamines impurities. We have available general methods by HS-GC-MS and LC-MS/MS for the N-nitrosamine analysis in API and drug products. These methods can be adapted with minor modifications to the client API or drug product.