In August of 2023, the FDA published a guidance document for evaluating the acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). This guidance allows for the calculation of specific AI limits for NDSRIs, based on the mutagenic and carcinogenic risk, which can range from 26.5 ng/day (the limit from past guidance) up to 1500 ng/day...
Read the full guidance here.
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