2-[2-[9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido[6,1-a]isoquinolin-3-yl]ethyl]isoindole-1,3-dione(CAS 3046226-90-5)는 프탈이미드 결합형 헤테로방향족 불순물로, 분자식 C33H32N4O5 및 분자량 564.642 g/mol을 갖는다. 이 구조는 후기 단계 결합 또는 측쇄 도입 과정에서 생성된 공정 유래 불순물임을 시사하며, 방향족 안정성과 이미드 모티프의 낮은 가수분해성으로 인해 잔존하기 쉽다. 확장된 융합 고리계와 2,4,6-트리메틸 치환 아닐리드 부분은 관련 공정 중간체와의 크로마토그래피 분리를 어렵게 한다. 미량 정량에는 일반적으로 고분해능 정확질량 확인이 가능한 LC-MS/MS가 필요하며, LC-UV 또는 LC-CAD의 직교적 평가가 보완된다. 구조적으로 유사한 헤테로고리성 불순물로서, 적용 시 ICH M7을 포함한 규제 불순물 관리 체계에서 평가된다.
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