Atorvastatin EP Impurity B (Free Base), CAS 842103-12-2는 아토르바스타틴 칼슘의 제조 경로 및 공정 또는 스트레스 조건에서의 스타틴 측쇄 변환과 연관된 구조 유사 합성 불순물이다. 분자식 C33H35FN2O5, 분자량 558.65 g/mol이며, 플루오로페닐 치환 피롤 약효단위를 유지하지만 입체배열 또는 치환기 배열이 원약과 달라 크로마토그래피 거동과 불순물 프로파일에 영향을 준다. 일반적으로 검출과 정량에는 역상 LC-UV, LC-MS/MS 또는 고해상도 MS가 필요하며, NMR에 의한 보완적 규명과 필요 시 LC-ELSD 또는 HPLC-UV를 이용한 미량 정량이 규제 기준 범위에서 수행된다.
References
McIver, L. A., & Siddique, M. S. (2022, September 2). Atorvastatin. Retrieved October 31, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK430779/
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