Levodopa Related Compound B; DL-3-O-Methyldopa (HCl Salt)
Descripción
Levodopa EP Impurity C (DL-3-O-Methyldopa | HCl | CAS 91013-37-5) es una impureza relevante en el control de calidad de la levodopa que resulta de reacciones de metilación y degradación del principio activo. Su identificación y cuantificación mediante métodos analíticos validados | especialmente HPLC con detección UV o MS | es crítica para cumplir especificaciones farmacéuticas y límites de impurezas. La presencia de esta impureza puede indicar rutas de degradación durante síntesis | almacenamiento o formulación; por ello se requieren estudios de estabilidad | perfiles de impurezas y estrategias de mitigación en procesos de fabricación para asegurar la seguridad y conformidad regulatoria.
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