Empagliflozin 1-Hydroxy Impurity, 즉 Empagliflozin Impurity B는 SGLT2 억제제의 C-글루코사이드 골격에서 유래한 공정 관련 산화 생성물이다. CAS 1279691-35-8, 분자식 C23H27ClO8, 분자량 466.91 g/mol로 정의된다. 1-하이드록실화는 모화합물에 비해 극성과 크로마토그래피 거동을 변화시키며, 아릴 에터 계통의 벤질성 위치에서의 대사적 또는 합성적 산화와 부합한다. 확인과 정량에는 일반적으로 정확질량 검증을 수반한 LC-MS/MS가 요구되며, HPLC-UV 또는 LC-CAD, 필요 시 구조 할당을 위한 NMR이 보완적으로 사용된다. 이는 불순물 프로파일링, 분해 연구, 규격 설정과 관련된다.
References
‘Wanner, Christoph, et al. “Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.†New England Journal of Medicine, vol. 375, no. 4, July 2016, pp. 323–34, https://doi.org/10.1056/nejmoa1515920. ?Frampton, James E. “Empagliflozin: A Review in Type 2 Diabetes.†Drugs, vol. 78, no. 10, June 2018, pp. 1037–48, https://doi.org/10.1007/s40265-018-0937-z ‘
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