Capecitabine USP Impurity H (Capecitabine 2-O-BDR Impurity) | CAS 1262133-66-3 | es una impureza relacionada del principio activo capecitabina que aparece por reacciones de degradación o como subproducto de síntesis durante la fabricación; su identificación y cuantificación son críticas para el control de calidad. Se detecta y cuantifica habitualmente por HPLC con detección UV | con confirmación por LC-MS y caracterización por RMN para asegurar asignación estructural. El monitoreo de Capecitabine USP Impurity H permite evaluar estabilidad del API | validar procesos de purificación y demostrar conformidad con límites de impurezas farmacopéicos | apoyando la gestión analítica y la seguridad del lote.
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