Salbutamol BP Impurity B / Albuterol Related Compound I / Salbutamol Deshydroxymethyl Impurity / t-Butylnorsynephrine
Descrição
Salbutamol EP Impurity B (Free Base) | CAS 96948-64-0 | conhecida também como Salbutamol BP Impurity B | Albuterol Related Compound I | Salbutamol Deshydroxymethyl Impurity e t-Butylnorsynephrine | é uma impureza orgânica observada em lotes de salbutamol por processos sintéticos e degradação química. Estruturalmente caracterizada pela perda do grupo hidroximetil | esta impureza pode ser quantificada por métodos cromatográficos sensíveis como HPLC com detecção UV e LC-MS para confirmação de massa. O controle inclui otimização de etapas de síntese | purificação e condições de armazenamento | além de limites especificados em monografias farmacopéicas. Monitoramento contínuo e procedimentos de validação analítica são fundamentais para garantir conformidade regulatória e segurança do produto.
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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