Salbutamol EP Impurity J는 salbutamol ketone impurity, salbutamone, Albuterol Related Compound B (free base)로도 불리며, phenethanolamine계 β2-작용제 골격에서 유래하는 비유전독성 공정 및 분해 불순물이다. 이 물질은 측쇄의 2차 알코올이 대응하는 케톤으로 산화된 구조를 가지며, aminoalcohol 골격을 유지하고 분자식 C13H19NO3, 분자량 237.29 g/mol, CAS 156547-62-5로 정의된다. 규제 불순물 프로파일링에서 극미량 정량은 일반적으로 LC-MS/MS를 필요로 하며, HPLC-UV 또는 NMR의 직교적 확인이 병행된다. 복잡한 매트릭스에서는 유도체화 기반 GC-MS가 유사한 catecholamine 유사체의 분리에 활용될 수 있다.
References
Ullmann, N., Caggiano, S., & Cutrera, R. (2015). Salbutamol and around. Italian Journal of Pediatrics, 41(Suppl 2), A74. https://doi.org/10.1186/1824-7288-41-s2-a74
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