La Impureza 6 de lisina en su forma de sal de fumarato es un contaminante relacionado observado durante síntesis y almacenamiento que puede afectar la pureza del principio activo y su perfil de disolución. Químicamente deriva de reacciones secundarias entre lisina y ácido fumárico o por rutas de degradación térmica y oxidativa. Su identificación y cuantificación requieren técnicas analíticas como HPLC con detección UV | cromatografía de alta resolución y espectrometría de masas confirmatoria. Su presencia por encima de límites establecidos puede alterar especificaciones de calidad y estabilidad | por lo que se recomienda establecer límites de control | condiciones de almacenamiento optimizadas y procedimientos de purificación adicionales.
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