Vancomycin Impurity
Time:2025-04-08
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Vancomycin is a high-molecular-weight glycopeptide compound used to treat bacterial infections. It acts by inhibiting the second stage of cell wall synthesis in susceptible bacteria while also altering cell membrane permeability and selectively inhibiting RNA synthesis.
In 1958, Eli Lilly introduced the world‘s first injectable vancomycin hydrochloride (branded as Vancocin®). However, due to primitive purification technology achieving only 70% purity (with 30% impurities).
1968,North China Pharmaceutical Group successfully developed a domestic "vancomycin," later found to lack N-methyl-leucine in its structure, making it actually N-demethyl vancomycin. 1988, China‘s Ministry of Health formally established quality standards for demethyl vancomycin, with North China Pharmaceutical;1990:,Demethyl vancomycin was included in the Chinese Pharmacopoeia.
From 2023 onward, the global vancomycin market continues to expand, with novel derivatives (e.g., daptomycin, teicoplanin) and third-generation vancomycin 3.0 entering clinical trials.
As the "gold standard" of glycopeptide antibiotics, vancomycin‘s quality control relies on precise impurity profiling. Key impurities originate from fermentation byproducts, degradation products, and synthetic intermediates. Established impurities including demethyl vancomycin (Impurity E/F) and deamino vancomycin (Impurity C/H) have been incorporated into the European Pharmacopoeia.
Early vancomycin preparations with 30% impurity content caused notable nephrotoxicity. Advancements in purification technologies (e.g., ion exchange chromatography, crystallization optimization) have reduced impurities to below 6%, significantly improving safety.
With global pharmacopeias tightening impurity limits and growing demands for innovative drug development, high-purity impurity reference standards have become essential for pharmaceutical quality control and research.
SZEB specializes in supplying comprehensive vancomycin impurities compliant with EP/USP standards, accompanied by COA, NMR spectra, and traceability documentation. Our services include trace impurity isolation, structural identification, and customized research solutions.
For detailed impurity specifications and technical inquiries:
Visit: http://www.ex-biotech.com
Hotline: +86-755-23051186
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