Impureza 3 de fenilefrina (sal de HCl) es un subproducto identificado en la síntesis y degradación del principio activo que requiere caracterización rigurosa para garantizar cumplimiento farmacéutico. Presenta mayor polaridad frente a la base libre y solubilidad en medios acuosos ácidos | lo que condiciona su comportamiento en cromatografía líquida HPLC y métodos LC-MS/MS. Su detección cuantitativa requiere límites de detección y cuantificación estrictos | validación de método y comparación con espectros NMR y MS para determinar estructura y pureza. El control sistemático de esta impureza es crítico en especificaciones de proceso y estudios de estabilidad para minimizar riesgos de seguridad y eficacia.
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