Atosiban Impurity 16 represents a related peptide species formed during atosiban manufacture or storage. Variations in residue composition or linkage pattern alter retention time and conformational profile. Researchers employ it to refine analytical separation and impurity thresholds. Applications include process-development insight, stability-indicating method design, and structural-variant analysis.
CAT No: R2738
Synonyms/Alias:(S)-N-((S)-5-amino-1-((2-amino-2-oxoethyl)amino)-1-oxopentan-2-yl)-1-((4R,7S,10S,13S,16R)-7-(2-amino-2-oxoethyl)-16-(4-ethoxybenzyl)-10-((R)-1-hydroxyethyl)-13-isopropyl-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carbonyl)pyrrolidine-2-carboxamide;Val3-Atosiban
Atosiban impurity 16 is a synthetic peptide derivative structurally related to the oxytocin antagonist atosiban, frequently encountered as a process-related impurity or degradation product in the manufacture and quality assessment of peptide-based pharmaceuticals. As a distinct peptide entity, it is characterized by specific sequence modifications that arise during the synthesis or storage of the parent compound. The presence and characterization of such impurities are of significant interest in peptide chemistry and pharmaceutical research, as they offer insights into synthetic efficiency, stability profiles, and the overall quality of peptide drug substances. Atosiban impurity 16 thus serves as a critical reference material for analytical method development and validation, supporting rigorous quality control in peptide manufacturing and research environments.
Analytical method development: In peptide pharmaceutical development, the availability of structurally defined impurities such as this one is essential for the establishment and validation of sensitive analytical techniques. Researchers use known peptide impurities to optimize chromatographic separation parameters, mass spectrometric detection, and quantitative assays, ensuring accurate identification and quantitation of related substances in complex mixtures. The inclusion of Atosiban impurity 16 as a reference standard enables laboratories to verify the specificity, linearity, and robustness of their analytical procedures, directly supporting regulatory expectations for impurity profiling in peptide therapeutics.
Quality control and batch release: The compound plays a pivotal role in quality control processes, where it is utilized as a benchmark for detecting and quantifying trace levels of process-related impurities in bulk peptide drug substances and finished formulations. By incorporating this impurity into routine batch analysis, manufacturers can monitor the consistency and purity of their products, identify potential process deviations, and implement corrective actions as needed. This practice is fundamental to maintaining high standards of product integrity and ensuring reliable performance of peptide-based pharmaceuticals in research and industrial applications.
Peptide stability studies: Atosiban impurity 16 is employed in forced degradation and stability-indicating studies to elucidate degradation pathways and assess the chemical resilience of peptide drug candidates. By spiking stability samples with known amounts of the impurity, researchers can evaluate the sensitivity and selectivity of their analytical methods under stress conditions such as heat, light, or oxidative environments. These investigations inform formulation strategies, packaging choices, and storage recommendations, ultimately contributing to the development of robust peptide products with well-characterized impurity profiles.
Process optimization in peptide synthesis: The identification and quantification of specific impurities, including this one, guide process chemists in refining synthetic routes and purification protocols for peptide active pharmaceutical ingredients. Monitoring the formation of Atosiban impurity 16 during process development allows for the pinpointing of reaction steps or conditions that may promote its generation. This information is instrumental in adjusting reagent selection, reaction parameters, and chromatographic purification strategies, thereby minimizing impurity formation and enhancing overall yield and product quality.
Structural elucidation and reference standardization: The compound is also valuable as a structurally characterized reference material for confirming the identity of unknown peaks observed in analytical profiles of peptide preparations. Its use in tandem mass spectrometry, nuclear magnetic resonance, and other structural elucidation techniques provides a reliable basis for distinguishing between various related substances. This capability is especially important in research and industrial settings where comprehensive impurity mapping is required for regulatory documentation, process validation, and continuous improvement of peptide manufacturing methodologies.
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