Temozolomide EP Impurity B | conocida también como Temozolomide Acid (CAS 113942-30-6) | es una impureza ácida que aparece por hidrólisis o degradación durante síntesis y almacenamiento. Su identificación y cuantificación son críticos para el cumplimiento de la monografía EP y de los requisitos ICH Q3A/Q3B | ya que la presencia no controlada puede afectar perfil de pureza y estabilidad del principio activo. Se recomienda su análisis mediante métodos validados de HPLC con detección UV y confirmación por LC-MS para caracterización y límites de aceptación. La evaluación de condiciones de proceso y de formulación permite minimizar su formación y asegurar calidad farmacéutica.
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