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# Explore Nitrosamine Impurity Mitigation Strategies: FDA
- URL: https://www.fdaweb.com/explore-nitrosamine-impurity-mitigation-strategies-fda/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150609

FDA says that since drug manufacturers should have completed a nitrosamine impurity risk assessment based on the timetable in a 2/2021 guidance, it is giving companies additional points to consider in developing their nitrosamine mitigation strategies that are due 10/1/2023\. An online [update](https://www.fda.gov/drugs/drug-safety-and-availability/updates-possible-mitigation-strategies-reduce-risk-nitrosamine-drug-substance-related-impurities?ref=fdaweb.com) says the agency has received additional reports of certain types of nitrosamine impurities that formed in several drug products. “These nitrosamine drug substance-related impurities (NDSRIs) are a class of nitrosamines sharing structural similarity to the active pharmaceutical ingredient,” it says. “NDSRIs can be generated during manufacturing or during the shelf-life storage period of the drug product.”

The agency says it expects manufacturers to ascertain the presence of nitrosamines, including NDSRIs, using the three-step mitigation strategy described in the guidance.

The document discusses potential innovative strategies and encourages manufacturers to consider them and other such strategies.