Amidotrizoic Acid EP Impurity B (CAS 162193-52-4) es una impureza relacionada que requiere monitoreo riguroso en el control de calidad. Se caracteriza por su aparición como subproducto o degradado durante la síntesis y el almacenamiento | y su identificación se realiza típicamente mediante HPLC con detección UV | LC-MS y confirmación por RMN. Su presencia puede alterar el perfil de pureza | el cumplimiento de especificaciones EP y la estabilidad del lote | por lo que se establecen límites y procedimientos de remediación. El control incluye optimización de síntesis | purificación adicional y pruebas de cuantificación validadas para garantizar la trazabilidad y conformidad regulatoria.
Referencias
Farag, Shawky A., and Clyde E. Wells. “Capillary Electrophoresis Determination of Diatrizoic Acid and Its Impurities in Diatrizoate Radiopaque Solutions.†Mikrochimica Acta, vol. 126, no. 1-2, Mar. 1997, pp. 141–145, 10.1007/bf01242676. Accessed 31 Jan. 2022.
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