Rivaroxaban Impurity III (CAS 1074-82-4) | conocido también como sal potásica de ftalimida o potassium phthalimide | es una impureza estructural relevante en el control de calidad de lotes farmacéuticos que contiene un núcleo isoindolínico. Como subproducto de reacciones de sustitución o hidrólisis durante síntesis y etapas de purificación | su presencia puede alterar el perfil de impurezas y requerir límites según ICH Q3A/Q3B. Su identificación y cuantificación se realiza habitualmente por HPLC-UV complementado con LC-MS y RMN para confirmación estructural. El control incluye especificaciones analíticas | métodos validados y estudios de estabilidad para minimizar riesgo a la calidad y seguridad del producto final.
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