Bicalutamide EP Impurity D, CAS 654-70-6는 4-Amino-2-(trifluoromethyl)benzonitrile로서, 5-Amino-2-cyanobenzotrifluoride 또는 4-cyano-3-(trifluoromethyl)aniline으로도 기술된다. 분자식 C8H5F3N2, 분자량 186.13 g/mol의 이 방향족 아닐린-니트릴은 분해산물보다는 Bicalutamide 합성 및 중간체 취급 과정에서 기원하는 공정 관련 불순물이다. 아닐린 유도체는 잔류 거동이 충분히 규명되지 않을 경우 ICH M7 관점에서 독성학적 검토 대상이 되며, 낮은 수준으로 관리되는 것이 일반적이다. 검출과 정량에는 적절한 유도체화를 동반한 LC-MS/MS, LC-HRMS 또는 GC-MS가 요구되며, 유사한 플루오로 및 트리플루오로메틸 이성질체와의 크로마토그래피 분리가 핵심이다.
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