Salbutamol BP Impurity B / Albuterol Related Compound I / Salbutamol Deshydroxymethyl Impurity / t-Butylnorsynephrine
Descripción
Salbutamol EP Impurity B (Free Base) | CAS 96948-64-0 | también conocida como Salbutamol BP Impurity B | Albuterol Related Compound I | Salbutamol Deshydroxymethyl Impurity o t-Butylnorsynephrine | es una impureza estructural relevante en el control de calidad de lotes de salbutamol. Su perfil analítico incluye masa molecular y fragmentación características detectables por LC-MS | retención típica en HPLC en fase reversa y señales específicas en RMN que facilitan su identificación. La cuantificación precisa mediante métodos validados es crítica para cumplimiento de especificaciones y límites de impurezas. La gestión de esta impureza exige límites | procedimientos de eliminación y documentación conforme a las guías regulatorias actuales.
Referencias
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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