Nitrosamines, Elemental Impurities, Extractable and Leachable – A New Normal for the Pharma Industry
Summary: Extractable and leachable (E&L), elemental and mutagenic impurities, such as nitrosamines, are important considerations in the safety assessment of small molecule drugs. Download this article to learn more about the current regulatory expectations for E&L, elemental impurities and nitrosamines testing, as well as the latest advances in analytical methods. Experts also share insights on how to expedite turnaround times during testing of pharmaceutical products while preserving product quality and safety.