Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs)

[Yosukemino]

I want to share previous discussions in this community. Members agreed on the MW correction, but we have never heard that the corrected AI from the read-across method used to control nitrosamines so far.

AIs for Complex Nitrosamines by MW Adjustments, any experience?

With the recent publication of FDA’s Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products | FDA A new concept have emerged: ‘nitrosamine drug substance-related impurities (NDSRIs)’ a class of nitrosamines sharing structural similarity to the API For this class of nitrosamines, the read-across when setting limits can be quite challenging. We have seen the case of N-nitroso-varenicline (37 ng/day). This afternoon Dr. Nudel…