Acalabrutinib N-Oxide는 BTK 억제제인 acalabrutinib에서 유래하는 산화성 공정 관련 불순물로, 주로 합성, 보관 또는 과산화물과 기타 활성산소종에의 노출 중 3차 아민의 N-산화에 의해 생성된다. 분자식 C26H23N7O3, 분자량 481.52 g/mol이며, 모화합물에 비해 극성과 크로마토그래피 거동이 달라 정성 및 정량에는 일반적으로 LC-MS/MS, 고분해능 질량분석, 그리고 직교적 HPLC 방법이 요구된다. 니트로사민은 아니지만, ICH Q3A/Q3B 및 관련 분해산물 평가 체계에서 불순물 관리 대상으로 검토된다.
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