Reference
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities Internet Document : 9 Aug 2023. Available from: URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-acceptable-intake-limits-nitrosamine-drug-substance-related-impurities
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Guidance on acceptable levels of NDSRI nitrosamine impurities. Reactions Weekly 1969, 9 (2023). https://doi.org/10.1007/s40278-023-44475-8
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DOI: https://doi.org/10.1007/s40278-023-44475-8