오시머티닙 N-옥사이드(CAS 2411395-22-5)는 EGFR 티로신 키나제 억제제 오시머티닙에서 유래하는 산화성 공정 관련 불순물로, 아크릴아마이드기를 포함한 헤테로방향족 골격의 3차 아닐린성 질소에 산소가 전달되어 형성된다. 분자식은 C28H33N7O3, 분자량은 515.62 g/mol이며, 안정성 및 불순물 프로파일링에서 관련물질로 평가된다. N-옥사이드 형성은 극성, 이온화 거동, 크로마토그래피 보유를 변화시키므로, 신뢰성 있는 확인과 정량에는 일반적으로 LC-MS/MS 또는 고분해능 LC-MS가 필요하고, LC-UV의 직교 확인이 병행된다. 그 관리 개념은 ICH Q3A 및 필요 시 M7 원칙과 연계된다.
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