UFMS Approach for Nitrosamine Analysis

Nitrosamine compounds are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC). Ever since the first U.S. Food and Drug Administration (FDA) notification in June 2018 about levels of these impurities in pharmaceutical AP, they have a reason of continuous discussion globally for analytical scientist, patients and regulators. After June 2018, the number recalls and 483’s have been on a rise for not only angiotensin II receptor blockers (-ARB, also called as sartans) but also for other products like Ranitidine, Metformin etc. FDA, European Medicine Agency (EMA) and international Council for Harmonization (ICH) have constantly set and update the guidelines in measuring impurities in pharmaceutical products.


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