Levetiracetam Impurity 21 (CAS 1847568-87-9) es una impureza relacionada que requiere control riguroso en el perfil de impurezas del principio activo. Su interés analítico radica en su posible formación por reacciones secundarias o degradación durante síntesis y almacenamiento | lo que puede comprometer pureza y estabilidad. La identificación y cuantificación se realizan mediante HPLC acoplada a espectrometría de masas (MS) y confirmación por espectroscopía RMN cuando procede. Su gestión incluye establecimiento de límites de aceptación | estrategias de eliminación en el proceso y validación de métodos analíticos para garantizar selectividad | recuperación y reproducibilidad en controles de calidad.
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