Phenylephrine EP Impurity A (Free Base) | CAS: 5596-07-6 | también conocida como norfenilefrina | es una impureza relacionada identificada en el perfil de pureza de Phenylephrine conforme a la Farmacopea Europea. Su caracterización abarca determinación de masa molecular | análisis por RMN y espectrometría de masas para confirmar estructura y vías de degradación. La monitorización se realiza mediante métodos validados de HPLC y LC-MS con límites de detección y cuantificación definidos | criterios de aceptación y estudios de estabilidad forzada. El control de proceso | límites especificados y procedimientos de limpieza son esenciales para minimizar su presencia y garantizar cumplimiento regulatorio y calidad del API.
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