DP Method transfer and verification

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I believe you will find this post handy. Publications and recent FDA presentations mentioned this…

Nitrosamines: Mass Spectrometry-Based Analytical Procedures

Are you facing significant challenges in your analytical methodology for quantifying nitrosamines? A collaborative effort involving various regulatory bodies occurred, including: US FDA, Health Canada, ANSM (France), Swissmedic (Switzerland), LGL (Germany), and TGA Laboratories (Australia). This partnership aimed to investigate the consistency of nitrosamine measurements. Each lab contributed its unique analytical methods to assess nitrosamine levels in standardized samples. In the paper title…