Salbutamol BP Impurity A; Salbutamol Methyl Ether; Levalbuterol Related Compound H
Descrição
Salbutamol EP Impurity A, também designada Salbutamol BP Impurity A, Salbutamol Methyl Ether e Levalbuterol Related Compound H, corresponde ao CAS 870076-72-5, com fórmula molecular C14H23NO3 e massa molecular de 253.34 g/mol. Esta impureza é o análogo éter O-metilado do salbutamol e pode surgir por metilação durante a síntese ou por transferências de alquilo associadas ao processo. Como impureza estruturalmente relacionada a agonistas β2, requer caracterização ortogonal por LC-MS/MS, HPLC com detecção por arranjo de diodos e, quando necessário, espectrometria de massa de alta resolução e RMN para confirmar a isomeria posicional. A sua avaliação integra perfis farmacopeicos de impurezas e estratégias de controlo de broncodilatadores relacionados.
Referências
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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