Nitrosamines Published Limits -reference

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I want to make reference to a great post discussion lead by @SusanFelter and @conudel related to setting AIs for complex Nitrosamines by MW adjustments. As example:

Molar adjustment relative to NDEA (MW = 102 g/mol; AI = 26.5 ng/day

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…