Vildagliptin (2R)-Isomer, CAS 1036959-27-9는 디펩티딜 펩티다아제-4 억제제인 빌다글립틴의 입체화학적 불순물로, 합성 중 에피머화 또는 불완전한 입체선택성에 의해 생성된다. 분자식 C17H25N3O2, 분자량 303.4 g/mol의 배위 이성질체로서 구조 유사체가 아니라, 결합 기하와 크로마토그래피 거동을 변화시킬 수 있다. 정량에는 일반적으로 키랄 LC와 UV 또는 MS 검출이 필요하며, LC-MS/MS, NMR, 필요 시 고분해능 질량분석으로 확인한다. 규제적으로는 ICH Q3A/Q3B의 불순물 관리 체계에서 공정 관련 불순물로 평가된다.
References
By Chantal Mathieu Container: Vascular Health and Risk Management Year: 2008 Volume: Volume 4 DOI: 10.2147/vhrm.s3005 URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2663430/
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