Levodopa EP Impurity D (D-Dopa | CAS 5796-17-8) es una impureza conocida en el perfil de calidad del principio activo levodopa; se caracteriza por su estructura isomérica y se detecta rutinariamente mediante técnicas cromatográficas y espectrométricas como HPLC con detector UV | LC-MS y RMN para confirmación estructural. Su presencia puede afectar la pureza y la estabilidad del lote | por lo que la monitorización cuantitativa y la asignación de límites en la especificación son críticas para cumplimiento regulatorio. Los métodos validados de preparación de muestras y control de procesos reducen su formación durante síntesis y almacenamiento | facilitando la trazabilidad en estudios de regresión y estabilidad.
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