29 April 2020 | News | By Ankit Kankar
Nitrosamine Impurities Quantification using LC-MS/MS and Challenges in Quality Control Laboratories Date: 28th April 2020 Time: 11:30 AM (Indian Standard Time)
The recent nitrosamine impurity crisis has firmly put the spotlight on genotoxic impurities (GTIs). Regulatory agencies, including US FDA and European Medicines Agency (EMA), have issued guidelines on allowable limits of genotoxic impurities in pharmaceutical products. These limits are to ensure product safety, not just for the ones frequently highlighted because of nitrosamines, but for all potentially contaminated drugs and processes in a company's portfolio of active pharmaceutical ingredients (APIs).
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