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 carbohydrate compound that plays a significant role in the research and development of peptide-based pharmaceuticals. As an identified impurity of teriparatide, this molecule is structurally related to the parent peptide but features specific modifications at the 8th and 18th methionine residues, which have been oxidized. Its presence and characterization are crucial for comprehensive analytical studies, enabling scientists to better understand the stability and degradation pathways of peptide therapeutics. The unique chemical nature of Teri-Met 8&18 (O) allows it to serve as a reference standard and research tool in various investigative and quality control settings, supporting the advancement of peptide drug development and manufacturing.
Pharmaceutical research: Teriparatide Impurity 1 is extensively utilized in pharmaceutical research to elucidate the degradation mechanisms of teriparatide formulations. By incorporating this impurity into forced degradation studies, researchers can simulate oxidative stress conditions and monitor the formation of oxidized peptide species. This approach helps in identifying potential degradation products that may arise during storage or handling, thereby informing the design of more robust formulations and packaging solutions. The use of Teri-Met 8&18 (O) in these studies enhances the understanding of peptide stability, leading to improved shelf-life and efficacy of peptide-based drugs.
Analytical method development: In the realm of analytical chemistry, Teri-Met 8&18 (O) serves as a critical reference material for the development and validation of chromatographic and spectrometric methods. Laboratories employ this impurity to establish the sensitivity, specificity, and accuracy of analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry. By spiking known quantities of the impurity into teriparatide samples, analysts can optimize their methods to reliably detect and quantify trace levels of oxidized peptides. This process ensures that routine quality control testing can effectively monitor product purity and identify any potential impurities that may impact safety or performance.
Process optimization and manufacturing: The identification and quantification of Teri-Met 8&18 (O) are integral to process optimization in peptide manufacturing. Understanding how and when this impurity forms during synthesis or storage enables process engineers to adjust reaction conditions, purification steps, and storage protocols to minimize its occurrence. Continuous monitoring of this oxidized species provides valuable feedback for refining production workflows, ultimately leading to higher yields of the desired peptide and reduced levels of unwanted byproducts. Incorporating this knowledge into manufacturing practices supports the consistent production of high-quality peptide therapeutics.
Stability studies: Teriparatide Impurity 1 is also a vital component in stability studies, where it is used to assess the long-term behavior of teriparatide under various environmental conditions. By tracking the formation and concentration of oxidized impurities over time, researchers can evaluate the impact of factors such as temperature, humidity, and light exposure on product integrity. These studies inform the development of appropriate storage guidelines and help predict the shelf-life of peptide drugs. The presence of Teri-Met 8&18 (O) as a marker for oxidative degradation facilitates more accurate and comprehensive stability assessments.
Peptide impurity profiling: Comprehensive impurity profiling is essential for the characterization of peptide therapeutics, and Teri-Met 8&18 (O) plays a pivotal role in this process. By including this impurity in impurity profiling studies, scientists can generate detailed impurity maps that account for all possible degradation products and process-related contaminants. This information is invaluable for risk assessment, batch release testing, and ongoing quality assurance. The use of Teri-Met 8&18 (O) in profiling efforts ensures that peptide products meet stringent quality requirements and supports the overall safety and efficacy of peptide-based medicines. Through its diverse applications in research, analysis, manufacturing, stability assessment, and impurity profiling, Teriparatide Impurity 1 (Teri-Met 8&18 (O)) remains a cornerstone in the scientific study and quality control of peptide therapeutics.
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