Teriparatide Impurity 3 (Teri-Met18(O)) features oxidation of methionine at position 18 to methionine sulfoxide. The modification increases polarity and perturbs local side-chain packing. Researchers monitor its formation to evaluate oxidative stability and degradation pathways. Applications include stress-testing studies, impurity specification, and redox-chemistry characterization in peptide formulations.
CAT No: Z10-101-228
Synonyms/Alias:Teriparatide Impurity 3 (Teri-Met 18(O)); L-seryl-L-valyl-L-seryl-L-glutamyl-L-isoleucyl-L-glutaminyl-L-leucyl-L-methionyl-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; Met(O)18-Teriparatide; H-Ser-Val-Ser-Glu-Ile-Gln-Leu-Met-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 3 (Teri-Met 18(O)) is a specialized carbohydrate compound that has garnered significant attention within the fields of peptide research and pharmaceutical development. As a structurally distinct impurity associated with teriparatide synthesis, Teri-Met 18(O) serves as a critical reference standard and analytical tool. Its unique molecular configuration allows researchers to scrutinize the subtleties of peptide modification and degradation, providing valuable insights into the stability and integrity of peptide-based therapeutics. The compound's well-characterized structure and behavior under various analytical conditions make it indispensable for method development, validation, and quality control processes in research laboratories focused on peptide drugs.
Analytical Method Development: In the context of analytical chemistry, Teri-Met 18(O) is widely utilized as a reference impurity for the development and optimization of chromatographic and spectrometric methods. By incorporating this impurity into system suitability tests, researchers can evaluate the sensitivity, specificity, and resolution of their analytical procedures, ensuring accurate separation and quantification of teriparatide and its related substances. This practice is essential for establishing robust analytical protocols that can reliably distinguish between the parent compound and structurally similar impurities, ultimately supporting the consistency and reproducibility of peptide drug analyses.
Peptide Stability Studies: The use of Teri-Met 18(O) extends to stability-indicating studies, where it plays a vital role in assessing the degradation pathways of teriparatide formulations. By monitoring the formation and behavior of this impurity under various stress conditions—such as changes in temperature, pH, and light exposure—scientists can gain a deeper understanding of the factors that influence peptide stability. This knowledge is instrumental in guiding formulation strategies, storage recommendations, and shelf-life predictions for peptide-based products, thereby enhancing product reliability and performance in research environments.
Process Impurity Profiling: Within the scope of process development and manufacturing, Teri-Met 18(O) is essential for comprehensive impurity profiling. Its presence and concentration serve as indicators of process efficiency and the effectiveness of purification steps during peptide synthesis. By systematically tracking this impurity, process chemists can identify critical control points and implement targeted optimizations to minimize impurity formation. This approach not only improves overall product quality but also supports the development of scalable and reproducible manufacturing processes for peptide therapeutics.
Reference Material for Quality Control: Teri-Met 18(O) functions as a crucial reference material in quality control laboratories, where it is employed to calibrate instruments and validate analytical methods. Its consistent and well-documented behavior under controlled conditions allows laboratories to benchmark their assays, verify system performance, and ensure data integrity. The use of such reference materials is fundamental to maintaining high standards of accuracy and reliability in the characterization of peptide drug substances and products.
Research on Peptide Modification Mechanisms: Beyond its utility in analytical and manufacturing settings, Teri-Met 18(O) is also a valuable tool for academic and industrial researchers investigating the mechanisms of peptide modification. By studying how this impurity is generated and how it interacts with other components in peptide formulations, scientists can elucidate the chemical and enzymatic processes that drive peptide oxidation and other modifications. These insights contribute to a broader understanding of peptide chemistry and facilitate the design of more stable and effective peptide-based molecules for research applications.
In summary, Teriparatide Impurity 3 (Teri-Met 18(O)) plays a multifaceted role in peptide science, supporting analytical method development, stability studies, process impurity profiling, quality control, and fundamental research into peptide modification mechanisms. Its integration into these diverse research and development workflows underscores its importance as a benchmark compound, enabling scientists to advance the characterization, optimization, and understanding of peptide therapeutics and their related substances.
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