Desmopressin EP Impurity C is a structurally related variant detected during desmopressin synthesis or aging. Small changes in residue connectivity or oxidation state alter disulfide geometry and chromatographic properties. Researchers employ it as a reference to validate impurity separation and identification. Applications include process characterization, stability profiling, and peptide-quality assessment.
CAT No: R2742
CAS No:160848-60-2
Synonyms/Alias:((R)-2-((S)-1-((4R,7S,10S,13S,16S)-7-(2-Amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carbonyl)pyrrolidine-2-carboxamido)-5-((diaminomethylene)amino)pentanoyl)glycine
Desmopressin EP Impurity C is a peptide-related compound recognized as a process impurity associated with the pharmaceutical synthesis of desmopressin, a synthetic analog of vasopressin. As a structurally defined impurity, it holds particular significance in the context of peptide manufacturing, analytical method development, and quality control within biochemical and pharmaceutical research. Its presence and characterization are critical for ensuring the integrity, safety, and efficacy of peptide-based active pharmaceutical ingredients (APIs), making it a valuable reference standard and research tool for laboratories engaged in the study and production of synthetic peptides.
Impurity profiling: In peptide synthesis and pharmaceutical manufacturing, the identification and quantification of process impurities such as Desmopressin EP Impurity C are essential for comprehensive impurity profiling. Analytical chemists utilize this compound as a reference material to establish impurity thresholds, validate analytical methods, and ensure compliance with pharmacopeial requirements for peptide drug substances. The availability of well-characterized impurities enables laboratories to monitor and control the quality of desmopressin preparations, thereby supporting robust risk assessments and facilitating regulatory submissions for peptide therapeutics.
Analytical method development: The structural similarity of this impurity to the parent peptide makes it an indispensable tool for the development and validation of chromatographic and spectrometric methods. Researchers incorporate it into method validation protocols to assess parameters such as specificity, accuracy, linearity, and detection limits. By using Desmopressin EP Impurity C as a test analyte, laboratories can optimize separation conditions and improve the reliability of impurity detection in complex peptide matrices, ensuring that analytical methods are fit for purpose in both research and quality control environments.
Peptide synthesis optimization: During the chemical synthesis of desmopressin and related analogs, the occurrence of side-products and impurities can influence overall process efficiency and product quality. Studying the formation pathways and structural characteristics of known impurities like this one allows process chemists to refine synthetic protocols, adjust reaction conditions, and implement purification strategies that minimize impurity formation. The use of Desmopressin EP Impurity C as a benchmark supports continuous improvement in peptide manufacturing processes, leading to higher yields and enhanced purity of the target peptide.
Reference standard for quality control: In regulated environments, the use of structurally authenticated impurities is crucial for the calibration and performance assessment of analytical instruments. Desmopressin EP Impurity C serves as a reliable reference standard in the routine quality control of peptide APIs, enabling laboratories to verify the accuracy of impurity quantification and maintain the consistency of batch release testing. Its inclusion in quality control protocols helps ensure that peptide products meet stringent quality specifications, reducing the risk of batch failures and supporting overall process reliability.
Structural elucidation studies: The availability of this impurity in isolated form facilitates advanced structural elucidation and characterization studies. Researchers employ techniques such as nuclear magnetic resonance (NMR) spectroscopy, mass spectrometry, and infrared (IR) spectroscopy to confirm its identity and investigate its physicochemical properties. These studies not only support the unambiguous assignment of impurity peaks in analytical profiles but also contribute to the broader understanding of peptide degradation pathways and stability, informing formulation development and long-term storage strategies for peptide-based compounds.
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