Osimertinib Dimer Impurity 3(CAS 2945220-41-5)는 오시머티닙의 제조 공정 또는 분해 화학과 연관된 이량체성 공정 유래 불순물로, 산화성, 열적 조건 또는 반응성 중간체 존재하에서 아닐리노 피리미딘 골격의 분자간 결합으로 형성될 수 있다. 분자식 C56H66N14O4와 분자량 999.24 g/mol은 비휘발성의 고분자량 종이며 헤테로원자 함량이 높고 크로마토그래피적 거동이 복잡함을 시사한다. 동정과 정량에는 고분해능 LC-MS/MS, LC-HRMS, 그리고 다이오드어레이 검출을 병용한 UPLC 기반의 직교적 불순물 프로파일링이 일반적으로 필요하다. 규제 관점에서는 ICH Q3A에 따른 평가가 필요하며, 구조적 경고가 존재할 경우 ICH M7 원칙에 따라 유전독성 가능성을 검토해야 한다.
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