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# Guide on Nitrosamine Acceptable Intake Limits
- URL: https://www.fdaweb.com/guide-on-nitrosamine-acceptable-intake-limits/
- Published: 2023-08-07T12:00:00.000Z
- Updated: 2026-09-14T18:48:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155038

*Federal Register* notice: FDA is making available a final guidance entitled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).” The document provides a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake limits for NDSRIs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-16814.pdf?ref=fdaweb.com).