Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation

[Yosukemino]

I agree with you, @Naiffer_Host. According to the paper, the conversion rate significantly depends on the conditions and structure of amines. And Swiss medic demonstrated the step 1 risk assessment by the pharmaceutical companies was sometimes unreliable.

Swiss Medic Guidelines

Remarkably indeed, there were no real indications that a data-driven risk assessment allows escaping the systematic testing obligation, also no indications that feeding toxicological data in the risk assessment to escape CPCA cat. 1-2 could allow no systematic testing. Of note, Swissmedic also said a few times that their interpret FDA is de facto aligned with their approach: “We discussed our strategy with EMA and FDA to attempt to get harmonization on the obligation for CPCA cat. 1-2 NDSRI te…

Especially for high-risk nitrosamines such as Category 1 or 2, confirmatory testing may be required.