Salbutamol EP Impureza O en forma de sal de clorhidrato es una impureza específica identificada en el perfil de calidad del salbutamol conforme a Farmacopea Europea. Su caracterización analítica requiere métodos robustos como HPLC con detección UV y LC-MS para confirmación de masa | complementados con RMN para elucidación estructural. La presencia de esta impureza puede afectar la pureza global y debe ser cuantificada en límites establecidos por la especificación del fabricante y autoridades regulatorias. Se recomiendan estudios de estabilidad y pruebas de degradación forzada para determinar su origen y establecer control de proceso | límites de aceptación y procedimientos de eliminación durante la fabricación.
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