La impureza de Fenilefrina clorhidrato (CAS 61-76-7) requiere un perfil analítico riguroso que aborde su identificación | cuantificación y origen en procesos sintéticos y de degradación; su presencia puede afectar la seguridad del principio activo y la estabilidad del lote | por lo que el control de calidad establece límites cuantitativos y criterios de aceptación basados en riesgo. Métodos validados como HPLC con detectores UV y espectrometría de masas permiten caracterizar trazas y productos relacionados | mientras que estrategias de mitigación incluyen optimización de reactivos | purificación cromatográfica y condiciones de almacenamiento controladas para minimizar formación y asegurar cumplimiento regulatorio.
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