Bicalutamide Impurity 4, CAS 327-74-2는 분자식 C8H5F3N2, 분자량 186.14 g/mol의 저분자 불소화 방향족 헤테로고리 화합물이다. 구조적으로는 2-아미노벤조트리플루오라이드 유래의 피리딘형 또는 아닐린 관련 공정 불순물에 부합하며, 통상 활성성분 합성 중 불완전한 고리화 또는 부반응에서 생성된다. 방향족 아민 특성과 트리플루오로메틸 치환으로 인해 극미량 분석에는 LC-MS/MS 또는 LC-HRMS가 주로 사용되며, NMR로 교차 확인하고 휘발성이 허용되면 GC-MS도 적용된다. 평가는 ICH Q3A 기준에 따르며, 변이원성 가능성이 있으면 ICH M7 관점에서 검토된다.
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