Nitrosamine Impurities in APIs: Causes, Risks & FDA Guidelines
In 2018, regulators pulled valsartan tablets off shelves worldwide after finding trace amounts of a chemical called NDMA inside the active ingredient. Ranitidine and metformin followed a similar path over the next two years. The common thread was a class of compounds known as nitrosamines, and the fallout changed how the entire industry looks at […]
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