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FDA Adds 12 High-Risk Nitrosamine Impurities, Spotlighting Meglumine-Related NDSRIs
Recently, the U.S. FDA updated its Nitrosamine Impurities Acceptable Intake Limits database, adding 12 new high-risk nitrosamine impurities. Among them, meglumine-related nitrosamine drug substance-related impurities (NDSRIs) have emerged as a major pharmaceutical safety concern, involving more than ten commonly used drugs such as delafloxacin meglumine, iopamidol meglumine, and gadodiamide meglumine.
CATO|CATO|2025-08-11 15:46:08Join us at CPHI China 2025 !
I am writing to invite to meet you in China CPHI on June 24-26, 2025, here is our Booth: # Hall E2G36. Please let me know your preferred meeting time, if you are there.
CATO|CATO|2025-08-04 11:14:55
