The Food and Drug Administration (FDA) is updating its guidance regarding Nitrosamine Drug Substance-Related Impurities (NDSRIs). With this update, the FDA acknowledges the leading scientific research by introducing a novel framework for determining the Acceptable Intake (AI) of NDSRIs.
This updated guidance defines five NDSRI potency categories and establishes a framework for setting a scientifically relevant AI based on the compound-specific chemical structures of identified NDSRIs. Most interestingly, the agency recognizes that setting a fixed AI limit for the total level of a mix of different nitrosamine impurities may be impractical if the potency categories of the implicated NDSRIs vary greatly.
This guidance is for immediate implementation, and the agency recommends reevaluating the NDSRI risk in your products before November 2023.
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