Citalopram Descyano Impurity (CAS 390817-87-5) es una impureza relacionada con la síntesis y la degradación del citalopram que puede aparecer durante procesos sintéticos y almacenamiento; su carácter crítico requiere identificación y cuantificación mediante técnicas analíticas sensibles como HPLC con detector UV y LC-MS para confirmar estructura y niveles en ppm. Su presencia puede comprometer la pureza del API | la estabilidad y el cumplimiento de especificaciones regulatorias | por lo que es necesario definir límites de aceptación | procedimientos de muestreo y validación analítica conforme a ICH Q3A/B. El conocimiento de su perfil fisicoquímico y rutas de formación permite implementar controles de calidad y estrategias de mitigación.
Referencias
Nickerson, Beverly. “The Determination of a Degradation Product in Clidinium Bromide Drug Substance by Capillary Electrophoresis with Indirect UV Detection.†Journal of Pharmaceutical and Biomedical Analysis, vol. 15, no. 7, Apr. 1997, pp. 965–71, https://doi.org/10.1016/s0731-7085(96)01922-x. ‌
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