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Nitrosamine Impurities and How Companies are Addressing the Crisis

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

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Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up

From the Neuland Reading Room

I thought I’d share some good reads this month. Have you checked out these articles? What did you think? 1989 to Present: PharmTech Highlights 30 Years of Bio/Pharma PharmTech tackles…

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How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

Posted in FDA, generic, method development, process chemistry, QA/QC, Quality, synthesis | Tagged , , , , , | Comments Off on How the Valsartan Contamination Happened: Its Context & Implications