Levofloxacin Impurity 38 (CAS 113211-53-3) es una impureza relacionada con el proceso de síntesis y degradación del principio activo levofloxacino | relevante para el control de calidad farmacéutico. Su identificación y cuantificación se realizan típicamente mediante HPLC acoplado a espectrometría de masas y confirmación por RMN | integrándose en el perfil de impurezas del lote. La presencia de esta impureza puede influir en la pureza | estabilidad y especificaciones del API | por lo que se requiere evaluación toxicológica | establecimiento de límites aceptables y estrategias de mitigación en desarrollo y estabilidad | conforme a guías regulatorias actuales.
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