Carvedilol Related Compound D, CAS 51997-51-4는 카바졸 에터 계열의 구조가 규정된 공정 유래 불순물로서 4-(Oxiranylmethoxy)-9H-carbazole, 즉 4-oxiranylmethoxy-9H-carbazole로 기술된다. 분자식은 C15H13NO2, 분자량은 239.27 g/mol이며, 반응성이 높은 에폭사이드 기능기를 포함하므로 carvedilol 제조 과정에서의 글리시딜성 중간체의 불완전 전환 또는 에폭시화 단계와 연관될 수 있다. 동정과 정량에는 LC-MS/MS, 고분해능 질량분석, HPLC가 일반적으로 필요하며, 필요 시 NMR 확인이 수행된다. 에폭사이드 함유 불순물은 알킬화 가능성이 있어 ICH M7 기반의 유전독성 불순물 평가에서 과학적으로 중요한 대상이다.
References
Carvedilol: MedlinePlus Drug Information. Medlineplus.gov, Jan. 2022, medlineplus.gov/druginfo/meds/a697042.html.
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