H-Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asn-Thr-Gly-Ser-Gly-NH2 (Disulfide bond between Cys1 and Cys7)
Pharmacopeial Synonyms
N/A
Sinónimos
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Descripción
La impureza Des (32,31) Thr en Pro-Calcitonin representa un producto de truncamiento peptídico localizado en los residuos C-terminales que puede alterar el perfil de pureza y la farmacocinética analítica del material; su identificación y cuantificación se realizan habitualmente por HPLC/UPLC acoplado a espectrometría de masas MS/MS y confirmación por fragmentación por CID. Esta variante surge por clivaje enzimático o degradación durante síntesis y almacenamiento, afectando la integridad estructural y potencialmente la actividad biológica, por lo que requiere límites especificados en el control de calidad, estudios de estabilidad forzados y métodos de mitigación como optimización de pH, inhibidores proteolíticos y condiciones de almacenamiento a baja temperatura.
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