H-Cys-Ser(Ac)-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-Thr-Pro-NH2 (Disulfide formation between Cys1 and Cys7)
Pharmacopeial Synonyms
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Sinónimos
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Descripción
Ser-2(Ac)-Calcitonin es una impureza peptídica acetilada relacionada con calcitonina, originada por una modificación sitio-específica del residuo de serina N-terminal y representativa de una variante asociada al proceso o a la degradación, más que de un degradante de bajo peso molecular. Con fórmula molecular C147H242N44O49S2 y masa molecular de 3473.93 g/mol, conserva el esqueleto de calcitonina enlazado por disulfuro y la complejidad fisicoquímica típica de los péptidos terapéuticos grandes. La elucidación estructural y la cuantificación suelen requerir LC-MS/MS con MS de alta resolución, complementadas por mapeo peptídico y resolución cromatográfica de análogos muy próximos. Su caracterización es relevante para el perfil de impurezas porque la acetilación puede modificar la unión al receptor, la estabilidad y la heterogeneidad de carga.
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