Información adicional sobre el Calcitonin Trisulphide Impurity
Fármaco de origen
Calcitonin
Nombre IUPAC
Calcitonin Trisulphide Impurity
Sinónimos
Trisulfide-Calcitonin
Descripción
Impureza de Calcitonin Trisulphide (Trisulfide-Calcitonin) es un derivado oxidado caracterizado por la sustitución del puente disulfuro por un puente trisulfuro entre residuos cisteína | lo que genera un incremento de masa aproximado de 32 Da y un comportamiento cromatográfico y de fragmentación distinto. Esta impureza afecta el plegamiento | la estabilidad y la potencia biológica del péptido | complica el mapeo de péptidos y puede elevar el riesgo inmunogénico. Se identifica y cuantifica mediante LC-MS de alta resolución | HPLC | mapeo peptídico y espectrometría tandem. Su control se basa en condiciones reductoras | optimización de almacenamiento y monitoreo en los lotes durante el aseguramiento de calidad.
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