Upadacitinib Amide Impurity는 모체 헤테로방향족 골격의 아마이드화 또는 가수분해성 재배열과 일치하는 공정 관련 유기 불순물로, 직접적인 유전독성 경고 구조에 해당하지 않는다. 분자식 C15H18N6O, 분자량 298.34 g/mol의 이 화합물은 최종 결합 단계, 수분 노출, 또는 아마이드화 반응 중 형성될 수 있는 규정된 분해산 또는 합성 부산물이다. 동정과 정량은 일반적으로 LC-MS/MS에 의한 질량 확인과, 근연체 분리를 위한 LC-UV 및 고해상도 질량분석을 필요로 한다. 규제적 평가는 불순물 기원, 공정 기여도, 크로마토그래피적 특이성에 대한 검토를 중심으로 수행된다.
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