Leuprolide Acetate EP Impurity E is a structurally related analog featuring modifications that alter folding, steric load, and ligand-recognition properties. Researchers employ it to study degradation pathways, structural variance, and receptor-interaction profiles. Its aromatic and charged residues support detailed conformational analysis. The acetate form aids solubility and handling.
CAT No: R2306
CAS No:1926163-23-6
Synonyms/Alias:(S)-N-Ethyl-1-(((S)-5-oxopyrrolidine-2-carbonyl)-L-histidyl-D-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl)pyrrolidine-2-carboxamide; L-Prolinamide, 5-oxo-L-prolyl-L-histidyl-D-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl; 1-9-Luteinizing hormone-releasing factor (swine), 3-D-tryptophan-6-D-leucine-9-(N-ethyl-L-prolinamide); [3-D-Tryptophane]leuprorelin;D-[Trp]3-Leuprolide; (S)-1-((3S,6R,9S,12S,15R,18S,21S)-3-((1H-imidazol-5-yl)methyl)-6-((1H-indol-3-yl)methyl)-21-(3-guanidinopropyl)-12-(4-hydroxybenzyl)-9-(hydroxymethyl)-15,18-diisobutyl-1,4,7,10,13,16,19-heptaoxo-1-((S)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20-heptaazadocosan-22-oyl)-N-ethylpyrrolidine-2-carboxamide;
Leuprolide Acetate EP Impurity E is a peptide-related compound structurally characterized as a defined impurity of leuprolide acetate, a well-known synthetic gonadotropin-releasing hormone (GnRH) analog. As an impurity standard, it holds significance for analytical and quality control workflows within pharmaceutical and biochemical research sectors. Its presence and quantification are critical for ensuring the integrity, safety, and efficacy of peptide-based therapeutics by enabling precise impurity profiling. The compound's defined structure and relevance to regulatory monographs make it an essential reference material for laboratories engaged in peptide analysis, method development, and product characterization.
Analytical method development: Leuprolide Acetate EP Impurity E serves as a valuable reference standard for the development and validation of analytical techniques such as high-performance liquid chromatography (HPLC), mass spectrometry, and capillary electrophoresis. By providing a known impurity profile, it enables researchers and quality control specialists to optimize detection parameters, enhance method sensitivity, and ensure the reliable separation and quantification of peptide-related impurities in complex matrices. This supports the establishment of robust, reproducible analytical protocols that are essential for regulatory compliance and product release.
Pharmaceutical quality control: The compound is routinely employed in the quality control testing of leuprolide acetate drug substances and finished products. Its use allows for the accurate identification and quantification of specific impurities, supporting batch release testing and ongoing stability studies. By benchmarking impurity levels against established thresholds, manufacturers can demonstrate adherence to pharmacopeial requirements and maintain high standards of product quality. This application is particularly important for mitigating the risks associated with impurity-related safety or efficacy concerns in peptide pharmaceuticals.
Process optimization and impurity profiling: During the synthesis and purification of peptide active pharmaceutical ingredients (APIs), monitoring the formation and clearance of related impurities such as EP Impurity E is essential. The compound provides a reference point for tracking synthetic byproducts and degradation products throughout process development. Its use aids chemists in refining reaction conditions, improving purification strategies, and minimizing impurity carryover, thereby enhancing overall process efficiency and product purity.
Stability studies: In forced degradation and long-term stability assessments, Leuprolide Acetate EP Impurity E is used to evaluate the degradation pathways and stability profile of leuprolide acetate formulations. By serving as a marker for specific degradation routes, it enables researchers to characterize the impact of environmental factors such as temperature, humidity, and light exposure on product integrity. The resulting data inform shelf-life determinations, packaging decisions, and storage recommendations for peptide-based pharmaceuticals.
Research and regulatory compliance: Laboratories involved in regulatory submissions and pharmaceutical development rely on well-characterized impurity standards to support comprehensive documentation and risk assessments. The availability of EP Impurity E as a reference material facilitates compliance with international guidelines for impurity identification, qualification, and quantification. Its inclusion in analytical workflows strengthens the scientific basis of regulatory filings and supports the transparent communication of impurity data to health authorities, enhancing confidence in the safety and quality of peptide therapeutics.
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