31-Dehydro-Thr Calcitonin es una impureza peptídica derivada de la deshidratación del residuo treonina en la posición 31 que plantea desafíos analíticos y regulatorios. Su detección y cuantificación requieren métodos cromatográficos y espectrométricos validados como HPLC-UV y LC-MS/MS debido a coeluciones y similitud de masas con el péptido nativo. Su presencia puede afectar la estabilidad farmacéutica, modificar la actividad biológica y aumentar el riesgo de inmunogenicidad, por lo que es crítica la optimización de las condiciones de síntesis y purificación, así como la definición de límites de especificación, estudios de degradación forzada y procedimientos de limpieza para asegurar cumplimiento analítico y calidad del lote.
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