Osimertinib 2-Amide Impurity, also designated N-(2-fluoro-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide, is an amide and acrylamide-related process impurity associated with the osimertinib scaffold. The substance, CAS 2213409-62-0, has molecular formula C23H20FN5O2 and molecular weight 417.44 g/mol. Its occurrence is typically attributed to incomplete amidation, hydrolytic or transamidation events, or side reactions during late-stage synthesis. Because the acrylamide motif can warrant toxicological scrutiny, trace-level monitoring is commonly addressed under ICH M7 principles using LC-MS/MS or high-resolution LC-MS, with orthogonal confirmation by HPLC-UV and, where needed, NMR characterization.
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