La impureza D de levetiracetam | registrada como CRS Y0001257 con CAS 103765-01-1 | es un compuesto contaminante caracterizado por su perfil analítico definido | masa molecular y espectros de RMN que facilitan su identificación en matrices farmacéuticas. Se genera por rutas de degradación hidrotermal y por reacciones secundarias durante la síntesis | presentando mayor presencia en etapas de purificación insuficiente. Su control requiere métodos validados como HPLC con detección UV | LC-MS y análisis de pureza por cromatografía de capa fina. La evaluación sistemática de esta impureza es crítica para establecer especificaciones | límites de aceptación y garantizar la integridad del principio activo.
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