Capecitabine Impurity 3 (Defluoro Capecitabine | CAS 216450-02-1) es una impureza relacionada definida por la ausencia del átomo de flúor en la estructura del capecitabine. Se forma como subproducto en etapas de síntesis y puede afectar la potencia y el perfil de degradación del ingrediente activo. Su identificación y cuantificación se realizan mediante técnicas analíticas exigentes como HPLC con detección UV | LC-MS y RMN para confirmar estructura y niveles. En control de calidad se establecen límites de aceptación | requisitos de identificación y métodos de eliminación mediante purificación cromatográfica y optimización de procesos. Información toxicológica limitada requiere monitorización estricta durante desarrollo y liberación.
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