Givinostat Impuriy 1, CAS 2485708-91-4는 히스톤 탈아세틸화효소 억제제 givinostat와 관련된 구조 규명된 공정 유래 불순물이다. 분자식 C24H25ClN2O3와 분자량 424.9 g/mol은 단순한 산화 분해보다 합성 단계에서의 부산물, 중간체 잔존 또는 불완전 전환에 더 부합하는 염소 치환 방향족 아마이드 골격을 시사한다. 이러한 불순물은 아실화, 알킬화 또는 커플링 단계에서 형성될 수 있으며, ICH Q3A에 따라 관리되어야 하고 유전독성 가능성이 있으면 ICH M7 관점에서도 평가된다. 검출과 정량에는 일반적으로 LC-MS/MS 또는 고분해능 LC-MS가 요구되며, NMR 및 필요 시 LC-UV로 보완 확인한다.
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