Carbetocin Impurity 2 is a minor peptide variant used as a reference to understand process-related changes in carbetocin production. Altered residues or linkages adjust hydrophobic packing and disulfide geometry. Researchers study its chromatographic and spectrometric signatures. Applications include analytical-method robustness testing, impurity fingerprinting, and synthetic-route refinement.
CAT No: Z10-101-205
CAS No:1631754-27-2
Synonyms/Alias:3-((3R,6S,9S,12S,15S)-6-(2-amino-2-oxoethyl)-3-((S)-2-(((S)-1-((2-amino-2-oxoethyl)amino)-4-methyl-1-oxopentan-2-yl)carbamoyl)pyrrolidine-1-carbonyl)-12-((S)-sec-butyl)-15-(4-methoxybenzyl)-5,8,11,14,17-pentaoxo-1-thia-4,7,10,13,16-pentaazacycloicosan-9-yl)propanoic acid
Carbetocin Impurity 2 is a synthetic peptide derivative structurally related to carbetocin, a well-characterized oxytocin analog. As a defined process-related impurity, it holds significant value in the context of peptide drug development, quality control, and analytical characterization. Its relevance extends to research efforts focused on understanding the synthesis, stability, and degradation pathways of peptide therapeutics, as well as in the refinement of manufacturing protocols. The availability of Carbetocin Impurity 2 supports rigorous scientific investigations aimed at ensuring the integrity and reproducibility of peptide-based pharmaceutical products.
Analytical method development: Carbetocin Impurity 2 serves as a critical reference standard in the development and validation of analytical methods such as high-performance liquid chromatography (HPLC) and mass spectrometry. By providing a well-characterized impurity profile, it enables researchers to establish robust detection, quantification, and separation protocols. This is essential for distinguishing the main peptide active pharmaceutical ingredient from structurally related byproducts, thereby ensuring the accuracy and sensitivity of analytical assays used in both research and industrial quality control environments.
Process optimization in peptide synthesis: The presence and quantification of specific impurities like Carbetocin Impurity 2 inform the optimization of synthetic methodologies for peptide production. By monitoring its formation during solid-phase peptide synthesis or solution-phase protocols, researchers can identify critical process parameters that influence impurity generation. This insight facilitates the refinement of reaction conditions, purification steps, and reagent selection, ultimately contributing to higher yield, purity, and consistency in peptide manufacturing.
Stability studies: Carbetocin Impurity 2 plays an important role in forced degradation and stability-indicating studies of peptide drug substances. Its inclusion in stress testing protocols helps elucidate degradation pathways, assess the impact of storage conditions, and evaluate the robustness of formulation strategies. By tracking the emergence and quantification of this impurity under various environmental factors, scientists can better predict shelf life and ensure the long-term stability of peptide-based products.
Regulatory compliance research: In the context of regulatory submissions and dossier preparation, well-characterized impurities such as Carbetocin Impurity 2 are essential for comprehensive impurity profiling. Their use enables researchers and manufacturers to demonstrate control over the synthetic process and provide detailed documentation of potential byproducts. This supports the preparation of thorough impurity risk assessments, which are fundamental requirements in pharmaceutical development and quality assurance.
Comparative structural studies: The defined structure of Carbetocin Impurity 2 allows for detailed comparative analyses with the parent peptide and other related analogs. Such studies are valuable for elucidating structure-activity relationships, investigating physicochemical properties, and understanding the potential impact of minor sequence modifications on peptide behavior. These insights contribute to broader research efforts in peptide chemistry, supporting the rational design of new analogs and the advancement of peptide science as a whole.
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