Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry Free PDF download

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This guidance is for immediate implementation

This guidance recommends steps manufacturers of APIs and drug products should take to detect
and prevent unacceptable levels of nitrosamine2 impurities in pharmaceutical products.3 The
guidance also describes conditions that may introduce nitrosamine impurities. The recent
unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs
such as angiotensin II receptor blockers (ARBs), 4 ranitidine, 5 nizatidine, 6 and metformin,
7 has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.

 

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