Quinina EP Impurity B (Base Libre) | CAS 485-71-2 | es una impureza estructural relacionada con la cinchonidina (sinónimos: Cinchonidine | (8-alpha | 9R)-Cinchonan-9-ol; 2-Quinuclidinemethanol | alpha-4-quinolyl-5-vinyl-; cinchonidine | (1beta | 3alpha | 4beta | 8alpha | 9R)-isomer; (1R)-quinolin-4-yl((2S | 4S | 5R)-5-vinylquinuclidin-2-yl)methanol) que presenta un perfil analítico característico en cromatografía líquida y espectrometría de masas | con fragmentación y tiempos de retención específicos que permiten su identificación y cuantificación en lotes farmacéuticos. Su presencia | incluso en niveles traza | puede afectar la pureza y el perfil farmacocinético del material de referencia de quinina. Se recomienda monitorización mediante métodos validados | límites de aceptación definidos y caracterización espectroscópica completa para cumplir la Farmacopea Europea y asegurar la calidad del material.
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