H-Cys-OH + H-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-Thr-Pro-NH2 (inter disulfide bridge between Cys1 and -Cys2 in two chains)
Beschreibung
1-2 Hydrolysis-Calcitonin is an N-terminal hydrolysis impurity arising from peptide bond cleavage between residues 1 and 2 of calcitonin. This degradation product exhibits a predictable mass shift and altered chromatographic retention, making it amenable to detection and quantification by LC-MS, HPLC peptide mapping and MS/MS fragmentation analysis. Presence of the 1-2 hydrolysis species can influence potency assays, immunoreactivity and overall product purity, and therefore is considered a critical quality attribute for stability and forced degradation studies. Analytical control strategies typically include targeted MS methods, stability-indicating HPLC assays and specification limits to monitor and mitigate formation during synthesis, storage and formulation.
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