Prucalopride-N-Galactopyranoside es una impureza de interés en el perfil de calidad que típicamente se origina por reacciones de glicosilación secundarias o transglicosilación durante la síntesis y purificación del principio activo. Su presencia puede alterar la pureza | la solubilidad y la estabilidad del lote | por lo que su identificación y cuantificación son críticas. Se caracteriza por HPLC con detección UV y LC-MS para determinación de masa | complementadas con RMN para confirmación estructural. El control se implementa mediante optimización de parámetros de reacción | cromatografía preparativa y métodos analíticos validados conforme a guías aplicables ICH | estableciendo límites de aceptación y procedimientos de liberación.
Referencias
Tameez Ud Din, Asim, et al. “Clinical Efficacy and Safety Profile of Prucalopride in Chronic Idiopathic Constipation.†Cureus, 4 Apr. 2019, 10.7759/cureus.4382.
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