Impureza ácido carboxílico de Sorafenib (CAS 1012058-78-4) es un degradado clave observado en el perfil de impurezas del principio activo. Caracterizada por la presencia del grupo carboxílico | esta impureza impacta la calidad del API y puede alterar parámetros de estabilidad y pureza. Su identificación y cuantificación se realizan mediante HPLC con detección UV y confirmación por LC-MS y RMN. Se recomienda establecer límites de especificación | realizar estudios de estabilidad forzada para evaluar su formación y validar métodos analíticos con límites de cuantificación bajos. Un control riguroso de materias primas y procesos minimiza su aparición y asegura cumplimiento regulatorio.
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