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
N/A
Sinônimos
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Descrição
Ser-2(Ac)-Calcitonin é uma impureza peptídica acetilada relacionada à calcitonina, formada por modificação sítio-específica do resíduo de serina N-terminal e interpretada como variante associada ao processo ou à degradação, em vez de degradante de baixa massa molecular. Com fórmula molecular C147H242N44O49S2 e massa molecular de 3473.93 g/mol, preserva o arcabouço de calcitonina com ponte dissulfeto e a complexidade físico-química típica de peptídeos terapêuticos de maior porte. A elucidação estrutural e a quantificação exigem, em geral, LC-MS/MS com MS de alta resolução, complementadas por mapeamento peptídico e separação cromatográfica de análogos muito próximos. Sua caracterização é relevante no perfil de impurezas, pois a acetilação pode alterar ligação ao receptor, estabilidade e heterogeneidade de carga.
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