European Pharmacopoeia Commission revises position on nitrosamine impurities

The European Pharmacopoeia Commission (EPC) has revised its strategy on the control of N -nitrosamine impurities, switching from providing advice in individual monographs on active substances to discussing the requirements in general documents.

EDQM Notice


Similar to what happened with USP <476> where impurities were going to be included in individual monographs (and in some cases briefly did) before reverting back to the general chapters because of the variations from formulation to formulation.

It is a sensible approach - there is a process for calculating the permissable limit of any API in any drug product now, along with the known small molecule nitrosamines - should enable a more consistent approach.


Another important aspect of this is the control of Nitrite levels in excipients. Again I would favour a light touch regarding this i.e. to avoid setting hard limits for nitrite within individual excipient monographs as the risk of Nitrosamine formation is linked to so many different factors