Nitrosamines, like any mutagenic impurity, are organic compounds capable of interacting with DNA and producing alterations that could ultimately lead to carcinogenic processes.

To control the presence of this type of impurities in the finished product, the ICH M7 (2014) has been developed. It proposes a strategy to follow to identify the actual and potential impurities that could appear in a product, as well as to evaluate its mutagenic profile and its corresponding toxicological limit. In addition, in cases where the presence of a mutagenic impurity is suspected by exceeding its established toxicological threshold, it will be necessary to justify its absence in the product, either through screening studies or through the corresponding confirmatory analytical tests.

 

What Netpharmalab offers to you…

At Netpharmalab and DALIA GLOBAL SERVICES, we have a team of expert toxicologists in risk analysis of mutagenic impurities and also in the development of analytical methods for their identification and control.