FDA: Updated Nitrosamine Limits
FDA’s CDER has updated the recommended acceptable intake (AI) limits for certain hypothetical nitrosamine drug substance-related impurities (NDSRIs) and other identified nitrosamine impurities (Table 1) as well as the recommended interim AI limits for certain nitrosamine impurities for approved or currently marketed products (Table 3).
To reflect the evolving and highly technical nature of the relevant information, FDA is providing certain updated information in connection with the guidance Control of Nitrosamine Impurities in Human Drugs, at its web page.
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