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USP Proposes Analytical Methods For Drug Makers To Detect Nitrosamine Impurities

 
• By Joanne S. Eglovitch

The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.

woman in a laboratory microscope with microscope slide in hand.toned image.
USP Proposes New Chapter On Nitrosamine Testing • Source: Shutterstock

The USP has proposed guidance on how to test active pharmaceutical ingredients and drug products for nitrosamine impurities, which have been discovered in a growing array of blood pressure medications and other pharmaceuticals.

The USP general chapter was proposed the day the US Food and Drug Administration issued guidance on controlling nitrosamines in all drug products. (Also see "US FDA Expectations For Removing Nitrosamines From All APIs, Drug Products" - Pink Sheet, 2 September, 2020

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