🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry

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FDA Recommended AI Limits for Certain Hypothetical NDSRIs

Updated Information Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Recommended AI Limits for Certain NDSRIs Based on Predicted Carcinogenic Potency Categorization for APIs at Hypothetical Risk of Forming Such NDSRIs APIs that contain secondary amine or dimethyl tertiary amine centers are at risk of forming NDSRIs by nitrosation of the amine center. This can occur under conditions related to the formulation and manufacturing process for the d…