Desmopressin Impurity 7

Desmopressin Impurity 7 is a minor structural variant generated by side-chain modification or incomplete deprotection. Small conformational differences affect disulfide-loop geometry and chromatographic elution. Researchers use it to enhance impurity identification and method specificity. Applications include stability testing, QC evaluation, and process-control refinement.

Designed for biological research and industrial applications, not intended for individual clinical or medical purposes.

CAT No: R2786

Synonyms/Alias:[Des-Asn5]-Desmopressin;(S)-N-((R)-1-((2-amino-2-oxoethyl)amino)-5-((diaminomethylene)amino)-1-oxopentan-2-yl)-1-((4R,7S,10S,13S)-7-(3-amino-3-oxopropyl)-10-benzyl-13-(4-hydroxybenzyl)-6,9,12,15-tetraoxo-1,2-dithia-5,8,11,14-tetraazacycloheptadecane-4-carbonyl)pyrrolidine-2-carboxamide

Custom Peptide Synthesis
cGMP Peptide
  • Registration of APIs
  • CMC information required for an IND
  • IND and NDA support
  • Drug master files (DMF) filing
M.F/Formula
C42H58N12O10S2
M.W/Mr.
955.12

Desmopressin Impurity 7 is a synthetic peptide-related compound that serves as a structurally defined byproduct or analog associated with the manufacture and quality assessment of desmopressin, a well-known vasopressin analog. As a characterized impurity, it holds significant importance in the context of pharmaceutical quality control, analytical method development, and peptide chemistry research. Its precise identification and availability enable researchers and manufacturers to better understand the chemical landscape of desmopressin synthesis, thereby supporting rigorous evaluation of product integrity, stability, and process optimization.

Analytical reference standard: In pharmaceutical development and quality assurance workflows, Desmopressin Impurity 7 is frequently utilized as a reference standard for high-performance liquid chromatography (HPLC), mass spectrometry (MS), and other advanced analytical techniques. By providing a well-defined benchmark, it facilitates the accurate detection, quantification, and differentiation of related substances during routine batch analysis and impurity profiling, thus ensuring the reliability of analytical data and compliance with stringent quality requirements.

Process impurity profiling: The compound plays a critical role in process development studies aimed at optimizing the synthetic route of desmopressin and related peptides. Its presence and quantification help researchers identify potential side reactions, degradation pathways, and process inefficiencies. This information is essential for refining purification strategies, minimizing impurity formation, and achieving consistent product quality during scale-up and commercial manufacturing.

Stability studies: Desmopressin Impurity 7 is employed in forced degradation and stability-indicating studies to assess the robustness of peptide formulations and storage conditions. By monitoring its formation and behavior under various stress factors such as heat, light, pH, or oxidizing environments, scientists gain valuable insights into the degradation mechanisms of desmopressin products, enabling the design of more stable formulations and improved shelf-life predictions.

Peptide synthesis research: In the context of peptide chemistry, this impurity provides a model system for investigating synthetic challenges and structure-activity relationships among desmopressin analogs. Its availability supports the development and validation of novel synthetic methodologies, purification techniques, and characterization protocols, ultimately contributing to advances in peptide manufacturing and analytical science.

Regulatory method validation: The inclusion of Desmopressin Impurity 7 in method validation protocols is vital for demonstrating the specificity, accuracy, and sensitivity of analytical procedures intended for impurity monitoring. By challenging the performance of these methods with structurally relevant impurities, laboratories can ensure that their assays are robust and fit for purpose, thereby supporting regulatory submissions and ongoing quality control efforts in the pharmaceutical sector.

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