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Control of Nitrosamine Impurities in Human Drugs
… /regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs … [Updated 2/24/21] This guidance …
Updated Information | Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)
… ts/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related … Subscribe for email … Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (August 2023) (NDSRI Guidance). To … Recommended Interim AI Limit (ng/day) Recommended Interim Control Limit (ppm) Estimated Duration*** …