El Prucalopride Lactose Adduct es una impureza formada por la reacción entre el grupo amino del principio activo y el poder reductor de la lactosa durante el procesamiento o almacenamiento. Este aducto afecta la pureza del lote y genera picos coeluyentes y señales de masa en análisis LC-MS/UPLC | complicando la cuantificación y el desarrollo de métodos indicativos de estabilidad. Su evaluación requiere estudios de degradación forzada | caracterización por espectrometría de masas de alta resolución y establecimiento de límites operativos basados en riesgo. Las estrategias de control incluyen selección de excipientes no reductores | optimización de condiciones de proceso y controles de almacenamiento para minimizar formación y asegurar cumplimiento de especificaciones.
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