Tofacitinib Amine Impurity\Tofacitinib Inhouse Impurity A
설명
토파시티닙 N-디사이노아세틸 불순물, 즉 토파시티닙 아민 불순물은 토파시티닙 측쇄 구축과 연관된 공정 유래 합성 중간체 잔류물이다. CAS 477600-74-1, 분자식 C13H19N5, 분자량 245.32 g/mol 은 원 경로 중간체의 시아노아세틸 기능기를 상실한 염기성 헤테로방향족 아민을 나타낸다. 이는 일반적으로 제조 과정에서의 불완전한 아실화, 탈보호, 또는 가수분해성 전환에서 기인하는 경로 불순물로 모니터링된다. 정량은 보통 LC-MS/MS, LC-UV의 직교적 확인, 경우에 따라 HRMS를 필요로 하며, ICH Q3A 및 M7 원칙에 부합하는 불순물 관리 체계에서 관련 아민 종과의 분리를 위해 사용된다.
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