Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate is an oxidized analogue featuring hydroxylation that alters polarity and retention behavior. Structural variation affects backbone geometry and hydrogen-bond potential. Researchers analyze it in impurity panels to validate chromatographic selectivity. Applications include QC profiling, degradation-pathway elucidation, and synthetic-route evaluation.
CAT No: Z10-101-172
CAS No:2901757-74-0 (free base)
Synonyms/Alias:((R)-2-((S)-2-((S)-2-((R)-2-((R)-2-((R)-2-acetamido-3-(naphthalen-2-yl)propanamido)-3-(4-chlorophenyl)propanamido)-3-(pyridin-3-yl)propanamido)-3-hydroxypropanamido)-3-(4-hydroxyphenyl)propanamido)-5-ureidopentanoyl)-L-leucyl-L-arginyl-L-prolyl-D-alanine , 2,2,2-trifluoroacetic acid (1:2)
Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate is a specialized peptide derivative that arises as a process-related impurity during the synthesis and manufacturing of cetrorelix, a well-known gonadotropin-releasing hormone (GnRH) antagonist. Structurally, this impurity features a hydroxyl modification, which can influence its physicochemical and biological properties relative to the parent compound. Its presence and characterization are of significant relevance in peptide chemistry, quality control, and regulatory-driven impurity profiling. As a research-use-only standard, Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate plays a critical role in method development, analytical validation, and the broader study of peptide synthesis fidelity.
Analytical method development: The availability of this impurity enables laboratories to design, optimize, and validate high-performance liquid chromatography (HPLC), mass spectrometry, and related analytical protocols for the detection and quantification of process-related impurities in cetrorelix preparations. By serving as a reference standard, it helps establish sensitivity, selectivity, and reproducibility in impurity profiling, thereby supporting robust quality control workflows in both research and industrial peptide production settings.
Peptide synthesis optimization: Investigation of Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate informs process chemists about potential side reactions and degradation pathways during solid-phase or solution-phase peptide synthesis. Understanding the formation mechanisms and conditions that favor this impurity enables researchers to refine synthetic protocols, adjust reagent choices, and implement process controls that minimize unwanted byproducts, ultimately enhancing overall yield and purity of the target peptide.
Impurity identification and structural elucidation: The well-defined structure of this impurity provides a valuable benchmark for the identification and confirmation of related species in complex peptide mixtures. Advanced spectroscopic and chromatographic studies utilizing this standard facilitate the assignment of retention times, fragmentation patterns, and spectral signatures, supporting comprehensive structural elucidation efforts in peptide research and pharmaceutical development.
Stability studies: The presence of Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate is instrumental in forced degradation and stability-indicating studies. By monitoring its generation under stress conditions such as oxidation, hydrolysis, or thermal exposure, researchers can evaluate the stability profile of cetrorelix formulations and assess the robustness of storage and handling protocols. These insights contribute to the development of stable peptide products and inform best practices in pharmaceutical logistics.
Regulatory compliance research: Accurate quantification and characterization of process-related impurities like this one are essential for meeting regulatory expectations in peptide drug development. Utilization of Cetrorelix Impurity 7 (+OH) Ditrifluoroacetate as a reference material supports the generation of comprehensive impurity profiles, risk assessments, and documentation required for regulatory submissions, thereby facilitating the advancement of robust quality assurance frameworks in the peptide manufacturing industry.
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