1-(3-Hydroxyphenyl)-2-[methyl(phenylmethyl)amino]ethanone Hydrochloride; Phenylephrine Imp. E (EP) Hydrochloride; Phenylephrine EP Impurity E;
Descripción
Fenilefrina EP Impureza E (base libre) | CAS 56917-44-3 | es una impureza reconocida en el perfil analítico de fenilefrina conforme a la Farmacopea Europea. Químicamente relacionada con 1-(3-Hydroxyphenyl)-2-[methyl(phenylmethyl)amino]ethanone y sus sales | su control es crítico en el aseguramiento de la calidad por su impacto en la pureza | estabilidad y cumplimiento de límites de impurezas. La identificación y cuantificación requieren métodos analíticos validados | típicamente HPLC con detección UV y LC-MS para confirmación estructural | junto con pruebas de relación masa/retención. La caracterización completa apoya liberación de lote y evaluación de riesgos durante desarrollo y fabricación.
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