H-Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Glu-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr-Pro-NH2 (Disulfide bond between Cys1 and Cys7)
Pharmacopeial Synonyms
N/A
Synonyms
N/A
Description
Glu-14-Calcitonin impurity is a positional peptide variant that alters charge distribution and chromatographic behaviour relative to the parent calcitonin sequence, presenting a distinct mass shift detectable by high resolution MS. This impurity often arises from misincorporation or incomplete side chain protection during solid phase peptide synthesis and can compromise potency, receptor binding and stability if not controlled. Analytical identification requires orthogonal techniques such as reversed phase HPLC, peptide mapping with MS/MS fragmentation and amino acid analysis to differentiate isobaric species and assess degradation pathways. Control strategies include optimized coupling chemistry, targeted purification by preparative HPLC and defined acceptance criteria informed by stress stability studies.
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