Abstract
Doxepin is used to treat anxiety or depression. It is also used to treat insomnia (trouble with sleeping). On 8/4/2023, FDA issued a final guidance on Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (August 2023) (RAIL Guidance) which provided recommendations for NDSRI AI limits based on predicted carcinogenic potency categorization. On 9/4/2024, FDA issued a final guidance on Control of Nitrosamine Impurities in Human Drugs (September 2024, Rev.2) (Nitrosamine Guidance). The Nitrosamine Guidance describes two classes of nitrosamines – small-molecule nitrosamines and NDSRIs; and also provides recommendations to industry on mitigation strategies to control nitrosamines and on implementation of these strategies. Manufacturers should reference these two guidances for information on determining AI limits and for recommendations on reducing or preventing nitrosamine impurities in their drug products. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.
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Recommended Citation
Anonymous, "Stability Enhancement of Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg", Technical Disclosure Commons, (March 20, 2025)
https://www.tdcommons.org/dpubs_series/7925