Norfloxacin EP Impurity I es una impureza referida en el monográfico europeo que puede formarse durante la síntesis | almacenamiento o degradación de norfloxacino. Desde un punto de vista analítico requiere monitorización por HPLC con detección UV y confirmación por LC-MS debido a su similitud cromatográfica con el principio activo. Su presencia puede afectar la seguridad y cumplimiento de especificaciones farmacopéyicas | por lo que se evalúan perfiles de degradación | vías de formación y límites aceptables en estudios de estabilidad y control de calidad. La identificación | cuantificación y métodos validados son esenciales para la gestión del riesgo químico en desarrollo y fabricación.
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