MetO8 | 18-Teriparatide (CAS 96420-15-4) is a well-characterized oxidative impurity resulting from bioprocessing or storage-induced oxidation of methionine residues at positions 8 and 18. This modified peptide exhibits a +16 Da mass shift and distinct LC retention behavior | readily identified by HPLC-UV and confirmed by LC-MS/MS peptide mapping and accurate mass measurement. Presence of MetO8 | 18 can reduce receptor affinity and alter potency | making tight control in specifications and stability studies essential. Mitigation strategies include oxygen exclusion | controlled pH | use of antioxidants | and robust purification. Quantitative monitoring | forced-degradation studies | and validated analytical methods support regulatory-compliant impurity control.
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