아프레밀라스트 설폰 불순물, 즉 Apremilast Impurity 17은 포스포디에스터레이스 4 억제제 아프레밀라스트의 산화된 설폰 유사체이며 CAS 2487573-01-1에 해당한다. 분자식 C23H26N2O8S, 분자량 490.54 g/mol로서, 합성 또는 저장 과정에서 티오에터 유래 황 중심의 과산화를 반영한다. 이 불순물은 변이원성 경고 구조가 아니라 공정 및 분해 관련 종으로 평가된다. 미량 수준의 특성 분석에는 일반적으로 LC-MS/MS, HRMS, 그리고 직교 HPLC 방법이 필요하며, 경우에 따라 UV 확인을 병행한다. 구조 확인은 질량 차이 분석과 불순물 프로파일링으로 지원된다.
References
Schafer, Peter. “Apremilast Mechanism of Action and Application to Psoriasis and Psoriatic Arthritis.†Biochemical Pharmacology, vol. 83, no. 12, June 2012, pp. 1583–90, https://doi.org/10.1016/j.bcp.2012.01.001.
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