Salbutamol EP Impurity J (Free Base) | CAS 156547-62-5 | também conhecida como Salbutamol BP Impurity J | Albuterol Related Compound B ou Salbutamone | é uma impureza cetônica formada pela oxidação do grupamento álcool secundário do salbutamol. Possui estrutura 2-(tert-butylamino)-1-[4-hidroxi-3-(hidroximetil)fenil]etanona e apresenta polaridade moderada e baixa volatilidade. É caracterizada por métodos cromatográficos e espectrométricos | incluindo HPLC-UV com métodos indicativos de estabilidade | LC-MS para confirmação de massa e RMN para elucidação estrutural. Estratégias de controle incluem otimização de pH e agentes redutores durante a síntese | técnicas de purificação cromatográfica e estabelecimento de limites analíticos em conformidade com monografias farmacopéicas.
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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