Atosiban Impurity D is a structurally related byproduct formed during atosiban synthesis, differing subtly in side-chain or ring connectivity. Researchers analyze its chromatographic resolution and spectral signature. The peptide aids in verifying impurity limits and method selectivity. Applications include quality control, peptide-process mapping, and degradation-pathway elucidation.
CAT No: Z10-101-222
Synonyms/Alias:N4-((2R)-1-((2S)-2-((5-amino-1-((2-amino-2-oxoethyl)amino)-1-oxopentan-2-yl)carbamoyl)pyrrolidin-1-yl)-3-mercapto-1-oxopropan-2-yl)-N2-((R)-3-(4-ethoxyphenyl)-2-(3-mercaptopropanamido)propanoyl)-L-isoleucyl-L-threonyl-L-asparagine;
Atosiban impurity D is a structurally defined synthetic compound classified as a process-related impurity associated with the manufacture and analytical characterization of Atosiban, a peptide-based oxytocin receptor antagonist. As a chemically distinct byproduct or degradation product, it holds significant importance for pharmaceutical research, quality control, and analytical method development. Its presence and quantification are critical for ensuring the safety, efficacy, and overall integrity of Atosiban as a drug substance, making Atosiban impurity D a valuable reference standard and research tool within the context of peptide drug development and regulatory compliance studies.
Analytical method development: Atosiban impurity D is extensively utilized in the development and validation of analytical procedures, such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS), for the identification and quantification of process impurities in peptide-based pharmaceuticals. By serving as a well-characterized standard, it enables researchers and quality control laboratories to establish sensitive, specific, and robust methods for impurity profiling, which is essential for demonstrating batch-to-batch consistency and meeting regulatory expectations for impurity control.
Pharmaceutical quality control: The compound plays a central role in routine quality assessment of Atosiban active pharmaceutical ingredient (API) and formulated products. Its use as a reference impurity allows for precise monitoring of impurity levels during manufacturing and storage, helping to ensure that the final product remains within acceptable safety and quality thresholds. This application is vital for risk assessment and for supporting the overall quality assurance strategy in peptide drug production.
Forced degradation and stability studies: Researchers employ Atosiban impurity D in forced degradation experiments to simulate potential degradation pathways of Atosiban under various stress conditions, such as exposure to heat, light, or oxidizing agents. By tracking the formation and behavior of this impurity over time, scientists gain valuable insights into the stability profile of the parent peptide, informing the design of robust formulations and appropriate storage conditions.
Impurity identification and structural elucidation: The availability of a pure sample of Atosiban impurity D facilitates the confirmation of its chemical structure through techniques such as nuclear magnetic resonance (NMR) spectroscopy and tandem mass spectrometry. This structural reference is instrumental in distinguishing between closely related impurities and degradation products, thereby enhancing the accuracy of impurity mapping and supporting regulatory submissions that require comprehensive impurity characterization.
Process optimization and manufacturing control: In the context of process development, Atosiban impurity D serves as a benchmark for evaluating and optimizing synthetic routes and purification strategies for Atosiban. By quantifying the formation of this impurity under varying conditions, process chemists can identify critical parameters that influence impurity generation, leading to improved process control, higher product purity, and increased manufacturing efficiency. This application supports continuous improvement efforts in peptide synthesis and aligns with industry best practices for impurity management.
3. The spatiotemporal control of signalling and trafficking of the GLP-1R
4. Adipose tissue is a key organ for the beneficial effects of GLP-2 metabolic function
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