Salbutamol EP Impurity J, também designada impureza cetona de salbutamol, salbutamone e Albuterol Related Compound B (base livre), é uma impureza de processo e degradação não genotóxica do arcabouço fenetanolamínico agonista β2. Estruturalmente, resulta da oxidação do álcool secundário da cadeia lateral para a cetona correspondente, preservando o motivo aminoálcool, com fórmula C13H19NO3, massa molecular 237,29 g/mol e CAS 156547-62-5. No perfil regulatório de impurezas, a quantificação em níveis traço geralmente requer LC-MS/MS com confirmação ortogonal por HPLC-UV ou RMN, e em matrizes complexas pode-se empregar GC-MS assistida por derivatização para resolver análogos catecolamínicos estreitamente relacionados.
Referências
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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