Osimertinib 2-Amide Impurity, 즉 N-(2-fluoro-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide는 osimertinib 골격과 연관된 아미드 및 아크릴아마이드 관련 공정 불순물이다. 이 물질은 CAS 2213409-62-0, 분자식 C23H20FN5O2, 분자량 417.44 g/mol을 가진다. 일반적으로 불완전한 amidation, 가수분해, transamidation 또는 후반 합성 단계의 부반응에서 기원한다. 아크릴아마이드 모티프는 독성학적 검토 대상이 될 수 있으므로, 미량 관리는 ICH M7 기준에 따라 수행되며 LC-MS/MS, 고분해능 LC-MS, 보조적으로 HPLC-UV 및 필요 시 NMR로 동정과 정량을 수행한다.
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