USP - CPCA Nitrosamines Case Study

Carcinogenic Potency Categorization Approach (CPCA)
A case study on 16 Nitrosamine Drug Substance-Related Impurities
CPCA_Nitrosamines_Case_Study-May2024-Final.pdf (902.8 KB)


Very useful document, thank you for sharing

I find it kind of amusing how NTTP is listed in the final table but is not categorized through CPCA - maybe because it should be listed as Category 2 and have an Acceptable Intake of 100 ng/day and not 37 ng/day? A limit which was not even set from data from the impurity but migrated from an structural analogue which I would argue is not as similar?

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Fantastic summery in minimum words easy to understand