La impureza (3R)-3-(((1-methoxy-1-oxobutan-2-yl)amino)methyl)hexanoic acid presenta un centro quirales y un grupo metoxi que afectan su polaridad y comportamiento cromatográfico | siendo identificable por HPLC con detección UV y confirmable por LC-MS y RMN 1H/13C. Se origina típicamente por reacciones secundarias durante la etapa de acilación o por impurezas de materia prima | y puede influir en la estabilidad del principio activo y en el perfil de seguridad si no se controla. Se recomienda incluirlo en el perfil de impurezas | definir límites de aceptación basados en toxicología | y aplicar métodos analíticos validados para monitorización de proceso y liberación.
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