Difelikefalin Impurity 20 represents a minor analog arising during difelikefalin synthesis or oxidation. Structural modification affects hydrophobic balance and peptide folding. Researchers use it to evaluate impurity separation and degradation kinetics. Applications include QC profiling, process-mapping, and structure-property studies.
CAT No: Z10-101-201
Synonyms/Alias:1-(L-phenylalanyl-D-leucyl-D-lysyl)-4-aminopiperidine-4-carboxylic acid
Difelikefalin Impurity 20 is a characterized peptide impurity associated with the synthetic production and analytical assessment of difelikefalin, a selective kappa opioid receptor agonist. As a structurally defined peptide fragment or analog, Difelikefalin Impurity 20 holds significant relevance in peptide chemistry and pharmaceutical research, especially within the context of quality control, method validation, and structural elucidation of peptide-based drug substances. Its presence and identification are crucial for ensuring the integrity, safety, and efficacy of difelikefalin during preclinical and manufacturing processes. The availability of such reference impurities supports rigorous scientific investigation into peptide purity profiles and facilitates compliance with advanced analytical standards in research and development settings.
Analytical Method Development: Difelikefalin Impurity 20 is frequently employed as a reference standard in the development and validation of chromatographic and spectrometric methods. By providing a well-characterized impurity profile, it enables researchers to optimize separation conditions and detection parameters for difelikefalin and its related substances. This application is essential for establishing robust, reproducible analytical protocols that accurately quantify and discriminate between the active pharmaceutical ingredient and its impurities within complex matrices.
Quality Control in Peptide Manufacturing: The use of Difelikefalin Impurity 20 as a benchmark facilitates comprehensive quality control during peptide synthesis and purification workflows. Its inclusion in analytical runs allows for the monitoring of process-related impurities, supporting the identification and quantification of by-products that may arise during solid-phase peptide synthesis or downstream processing. This approach helps manufacturers maintain stringent quality specifications and supports the release of high-purity peptide products for research purposes.
Peptide Structural Characterization: Researchers utilize Difelikefalin Impurity 20 to aid in the structural elucidation of difelikefalin and its analogs. By comparing analytical data such as retention times, mass spectra, and fragmentation patterns, scientists can confirm the identity and structural integrity of the primary peptide as well as its impurities. This comparative analysis is vital for elucidating degradation pathways, understanding structure-activity relationships, and supporting comprehensive impurity profiling studies.
Stability Studies: The presence of Difelikefalin Impurity 20 is instrumental in conducting forced degradation and stability-indicating studies for difelikefalin formulations. By intentionally subjecting the peptide product to stress conditions and tracking the formation or persistence of known impurities, researchers can assess the chemical stability and degradation kinetics of the active substance. These studies provide critical insights into product shelf life, storage requirements, and formulation robustness under various environmental conditions.
Regulatory Documentation Support: In the context of regulatory submissions for research-use peptides, comprehensive impurity characterization is a key requirement. Difelikefalin Impurity 20 serves as an essential reference in the preparation of impurity profiles and supporting documentation. Its accurate identification and quantification underpin the scientific rationale for impurity limits, contributing to the overall risk assessment and quality justification presented in technical dossiers for research and development applications.
1. C-Peptide replacement therapy and sensory nerve function in type 1 diabetic neuropathy
3. SERS spectrum of the peptide thymosin‐β4 obtained with Ag nanorod substrate
4. The spatiotemporal control of signalling and trafficking of the GLP-1R
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