Teriparatide Impurity 1 (Teri-Met 8&18(O)) contains oxidized methionine sulfoxides at positions 8 and 18 within the teriparatide backbone. Dual oxidation events enhance polarity and can disrupt hydrophobic packing and helix stability. Researchers monitor its formation under stress conditions to assess redox sensitivity. Applications include degradation-pathway elucidation, impurity specification, and peptide-stability analysis.
CAT No: Z10-101-229
Synonyms/Alias:L-seryl-L-valyl-L-seryl-L-glutamyl-L-isoleucyl-L-glutaminyl-L-leucyl-L-methionyl(O)-L-histidyl-L-asparagyl-L-leucyl-glycyl-L-lysyl-L-histidyl-L-leucyl-L-asparagyl-L-seryl-L-methionyl(O)-L-glutamyl-L-arginyl-L-valyl-L-alpha-glutamyl-L-tryptophyl-L-leucyl-L-arginyl-L-lysyl-L-lysyl-L-leucyl-L-glutaminyl-L-alpha-aspartyl-L-valyl-L-histidyl-L-asparagyl-L-phenylalanine; Teriparatide Impurity-1 (Teri-Met 8&18 (O)); Met(O)-8,18-Teriparatide; H-Ser-Val-Ser-Glu-Ile-Gln-Leu-Met(O)-His-Asn-Leu-Gly-Lys-His-Leu-Asn-Ser-Met(O)-Glu-Arg-Val-Glu-Trp-Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-His-Asn-Phe-OH
Teriparatide Impurity 1 (Teri-Met 8&18 (O)) is a specialized peptide derivative that serves as a structurally defined impurity standard associated with teriparatide, a recombinant form of parathyroid hormone fragment 1-34. As a modified peptide, it features specific methionine oxidations at positions 8 and 18, providing a valuable tool for analytical, quality control, and stability studies within peptide pharmaceutical research. The unique sequence modifications present in this impurity reflect potential degradation pathways or synthetic byproducts, making it highly relevant for laboratories involved in peptide drug development, characterization, and regulatory compliance studies.
Analytical method development: In pharmaceutical research and manufacturing, the presence of peptide impurities is a critical quality attribute. Teriparatide Impurity 1 is widely utilized as a reference standard for the development and validation of chromatographic assays, such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS), to ensure robust detection, separation, and quantification of related substances in teriparatide products. Its defined structure enables precise calibration and method optimization, supporting accurate impurity profiling during both process development and final product release.
Stability studies: The oxidized methionine residues in this impurity provide a model for studying the oxidative degradation of peptide therapeutics under various storage and stress conditions. Researchers employ this compound to simulate and monitor the formation of oxidation products in teriparatide formulations, thereby gaining insights into the peptide's stability profile. These studies inform formulation strategies, packaging decisions, and shelf-life determination, contributing to the overall quality assurance of peptide-based pharmaceuticals.
Peptide degradation pathway elucidation: Understanding the specific degradation mechanisms of therapeutic peptides is essential for optimizing manufacturing processes and ensuring product safety. The availability of Teriparatide Impurity 1 allows scientists to investigate the pathways and kinetics of methionine oxidation within the teriparatide molecule. By comparing analytical signatures and degradation patterns, researchers can differentiate between process-related and storage-induced impurities, informing risk assessments and process control strategies.
Quality control and regulatory support: The use of well-characterized peptide impurities is integral to meeting regulatory expectations for impurity identification and quantification in drug substances and finished products. Laboratories incorporate this impurity standard into routine quality control protocols, enabling the establishment of impurity limits and supporting regulatory submissions. Its defined chemical identity and relevance to the parent peptide facilitate compliance with guidelines for impurity testing and reporting in peptide pharmaceuticals.
Comparative peptide characterization: The presence of specific modifications in Teriparatide Impurity 1 makes it an important tool for comparative studies involving structure-activity relationships and analytical differentiation between native and modified peptide species. Researchers utilize this compound to assess the impact of methionine oxidation on peptide conformation, bioanalytical detectability, and potential immunogenicity. Such comparative analyses enhance the understanding of peptide behavior in complex matrices and support the refinement of analytical and manufacturing protocols.
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