La impureza Vildagliptin Dipirrolidina (CAS 6708-06-1) es un subproducto estructural derivado de la incorporación del fragmento dipirrolidina en la síntesis de vildagliptina y requiere evaluación rigurosa en el perfil de impurezas del API. Su identificación y cuantificación se realiza mediante HPLC con detección UV y confirmación por LC-MS y RMN | prestando atención a tiempos de retención y patrones de fragmentación característicos. Puede formarse por rutas de reacción secundarias o por degradación durante el proceso y afectar estabilidad | pureza y cumplimiento de especificaciones. Su control incluye optimización de condiciones de síntesis | purificación cromatográfica y límites de aceptación documentados conforme a guías regulatorias.
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