Difelikefalin Dimer Impurity 1

Difelikefalin Dimer Impurity 1 features a higher-order peptide association, often through intermolecular coupling or condensation. Dimerization modifies hydrodynamic radius, conformational ensemble, and binding characteristics. Researchers monitor its formation to understand aggregation pathways and synthetic side reactions. Uses include analytical-method stress testing, impurity mapping, and peptide-stability investigations.

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

CAT No: Z10-101-203

Synonyms/Alias:1-(N2-D-phenylalanyl-D-phenylalanyl-D-leucyl-N6-(1-(D-phenylalanyl-D-phenylalanyl-D-leucyl-D-lysyl)-4-aminopiperidine-4-carbonyl)-D-lysyl)-4-aminopiperidine-4-carboxylic acid; 4-amino-1-((R)-6-(4-amino-1-((R)-6-amino-2-((R)-2-((R)-2-((R)-2-amino-3-phenylpropanamido)-3-phenylpropanamido)-4-methylpentanamido)hexanoyl)piperidine-4-carboxamido)-2-((R)-2-((R)-2-((R)-2-amino-3-phenylpropanamido)-3-phenylpropanamido)-4-methylpentanamido)hexanoyl)piperidine-4-carboxylic acid

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
C72H104N14O11
M.W/Mr.
1341.68

Difelikefalin Dimer Impurity 1 is a specialized carbohydrate-based compound recognized for its significance in analytical and pharmaceutical research. As a structurally unique impurity associated with the synthetic peptide difelikefalin, this dimeric impurity offers valuable insights into the chemical stability, degradation pathways, and synthetic fidelity of peptide-based drugs. Its distinct molecular architecture provides a critical reference standard for researchers aiming to discern the presence and impact of related substances during drug development and quality assessment. By enabling precise identification and quantification, Difelikefalin Dimer Impurity 1 supports the comprehensive profiling of manufacturing processes and contributes to the advancement of peptide chemistry.

Analytical Method Development: Difelikefalin Dimer Impurity 1 plays a pivotal role in the development and validation of analytical methods for impurity profiling. Laboratories utilize this compound as a reference standard to establish the sensitivity, specificity, and robustness of chromatographic and spectrometric techniques. By incorporating the dimer impurity into method development workflows, scientists can accurately determine the limits of detection and quantification, ensuring that analytical procedures are capable of distinguishing between the parent peptide and its related impurities. This is essential for maintaining the integrity of both research and production environments, where precise impurity characterization underpins the reliability of analytical results.

Process Optimization in Peptide Synthesis: The presence of Difelikefalin Dimer Impurity 1 provides critical feedback for optimizing synthetic protocols. During the manufacturing of peptide therapeutics, the formation of dimeric impurities can signal inefficiencies or side reactions inherent to the process. By monitoring the levels of this impurity, chemists can adjust reaction conditions, purification strategies, and reagent selections to minimize unwanted byproducts. This iterative approach enhances yield, purity, and overall process efficiency, ultimately supporting the production of high-quality peptide compounds with consistent characteristics.

Structural Elucidation and Mechanistic Studies: The unique structure of the dimer impurity serves as a model for investigating peptide dimerization mechanisms. Researchers employ Difelikefalin Dimer Impurity 1 to study intermolecular interactions, aggregation behaviors, and the chemical factors that drive dimer formation. These investigations deepen the understanding of peptide chemistry, inform the design of more stable analogs, and guide the development of strategies to mitigate undesired aggregation. Such mechanistic insights are invaluable for both academic research and industrial applications, where control over peptide structure and function is paramount.

Quality Control and Stability Testing: In the context of pharmaceutical manufacturing, the dimer impurity is instrumental in establishing robust quality control protocols. By incorporating it into stability studies, laboratories can assess the propensity of difelikefalin formulations to generate related impurities under various storage and handling conditions. This enables the identification of critical control points and the implementation of measures to preserve product integrity throughout the supply chain. The use of Difelikefalin Dimer Impurity 1 as a benchmark ensures that stability-indicating methods are comprehensive and that finished products meet stringent quality expectations.

Comparative Research and Reference Standardization: Difelikefalin Dimer Impurity 1 is frequently employed in comparative studies, where its presence and concentration are evaluated alongside other process-related impurities. This facilitates the standardization of impurity profiles across different production batches and research laboratories, enabling consistent benchmarking and data interpretation. By serving as a reference material, it supports the harmonization of analytical practices and contributes to the establishment of best practices in peptide impurity analysis. The integration of this compound into research and development pipelines not only advances scientific understanding but also fosters innovation in the field of peptide therapeutics and analytical chemistry.

InChI
InChI=1S/C72H104N14O11/c1-47(2)41-57(83-65(91)59(45-51-25-13-7-14-26-51)81-61(87)53(74)43-49-21-9-5-10-22-49)63(89)79-55(29-17-19-35-73)67(93)85-37-31-71(76, 32-38-85)69(95)78-36-20-18-30-56(68(94)86-39-33-72(77, 34-40-86)70(96)97)80-64(90)58(42-48(3)4)84-66(92)60(46-52-27-15-8-16-28-52)82-62(88)54(75)44-50-23-11-6-12-24-50/h5-16, 21-28, 47-48, 53-60H, 17-20, 29-46, 73-77H2, 1-4H3, (H, 78, 95)(H, 79, 89)(H, 80, 90)(H, 81, 87)(H, 82, 88)(H, 83, 91)(H, 84, 92)(H, 96, 97)/t53-, 54-, 55-, 56-, 57-, 58-, 59-, 60-/m1/s1

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