Salbutamol BP Impurity A; Salbutamol Methyl Ether; Levalbuterol Related Compound H
설명
Salbutamol EP Impurity A는 Salbutamol BP Impurity A, Salbutamol Methyl Ether, Levalbuterol Related Compound H로도 지칭되며, CAS 870076-72-5, 분자식 C14H23NO3, 분자량 253.34 g/mol에 해당한다. 이 불순물은 살부타몰의 O-메틸화 에테르 유도체로서, 합성 중 메틸화 또는 공정 유래 알킬 전달 반응에 의해 형성될 수 있다. β2 작용제와 구조적으로 관련된 불순물로서 LC-MS/MS, 다이오드 어레이 검출 HPLC, 필요 시 고분해능 질량분석 및 NMR에 의한 직교적 동정이 요구되며, 위치 이성질체 확인이 핵심이다. 그 평가는 약전 불순물 프로파일과 관련 기관지확장제의 불순물 관리 체계에 포함된다.
References
Ullmann, N., et al. Salbutamol and Around.†Italian Journal of Pediatrics, vol. 41, no. Suppl 2, 2015, p. A74, https://doi.org/10.1186/1824-7288-41-s2-a74. ?
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