USP Nitrosamine Impurities Chapter Reflects Careful Coordination With US, EU Authorities
The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.
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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.
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.
As Recalls Multiply, EU Agency Studies How To Rid Chinese Firm’s Valsartan API Of Probable Carcinogen
European authorities are examining how a manufacturing process change six years ago may have introduced a probable carcinogen into Zhejiang Huahai’s valsartan API that was only recently detected. They hope to learn how the firm could reduce or eliminate the impurity.