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Cleaning Validation Glossary


Carcinogenic impurity

The chemical formula for nitrosamines (short for N-nitrosamines) is R₂N−N=O. They feature a nitroso group bonded to a deprotonated amine which may occur during the production of pharmacueticals. Nitrosamines belong to a group called "cohort of concern" meaning they are carcinogenic impurities that form during manufacturing and must be appropriately detected and controlled. FDA issued a guidance for industry, Control of Nitrosamine Impurities in Human Drugs, in September 2020 to combat the risks of nitrosamine impurities. This guidance outlines common nitrosamines and actions to be taken by facilties to reduce the risk of carryover into drug products.

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