Nitrosamine

Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products, as well as for new drug applications. There will be three…
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Nitrosamine risk mitigation is front of mind for many drug formulators following the discovery of N-nitrosodimethylamine (NDMA) in valsartan – a commonly used drug in the treatment of high blood pressure and heart failure. To learn more about the situation, DSM interviewed Prof. Gerhard…
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