Regulatory aspects of Nitrosamine impurities

Nitrosamine impurities became a focus for authorities in July 2018, when they announced a recall of angiotensin II receptor blocker (ARB) medicines, known as “sartans”, due to the presence of an impurity, N-nitrosodimethylamine (NDMA). The source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. Nitrosamines are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens,” Thus, addressing these impurities in drug substances and drug products has become of utmost importance from a regulatory perspective.

Category: Crash Courses

Duration : Training duration: 75 minutes, course would be accessible for 1 month from the date of admission

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