Cetirizine EP Impurity B (Free Base) | CAS 113740-61-7 | es una impureza identificada en el proceso de síntesis y almacenamiento de cetirizina que requiere vigilancia analítica por su potencial impacto en la calidad del principio activo. Presenta propiedades fisicoquímicas y comportamientos cromatográficos distintivos que permiten su separación y cuantificación por HPLC con detección UV y confirmación mediante espectrometría de masas y RMN. Su monitoreo es esencial para el control de calidad conforme a las directrices ICH sobre impurezas. Se describen rutas de formación | estabilidad en diversas condiciones y procedimientos de cuantificación y aislamiento para la validación de métodos analíticos.
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