Impureza Salbutamol EP Impurity B (sal de HCl) es un degradado y subproducto de síntesis conocido como Salbutamol Deshydroxymethyl o Albuterol Related Compound I | también referenciado como Salbutamol IP Impurity A y Salbutamol BP Impurity B. Se caracteriza por un perfil físico-químico y masa molecular distintivos que requieren identificación por HPLC con detección UV y confirmación mediante LC-MS y espectrometría de masas por fragmentación. Su aparición suele indicar rutas de deshidroxilación o reacciones secundarias durante síntesis o almacenamiento | por lo que su cuantificación y control dentro de límites aceptables es esencial para el aseguramiento de la calidad y la validación analítica.
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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