Agarose-gel electrophoresis for the quality assurance and purity of heparin formulations
Research article published in Journal of pharmaceutical and biomedical analysis (2012)
Abstract
The adulteration of raw heparin (Hep) with a synthetic oversulfated chondroitin sulfate (OSCS) not found in nature produced in 2007-2008 a global crisis giving rise to the development of additional, new and specific methods for its quality assurance and purity. In this study, a simple and sensitive agarose-gel electrophoresis method has been developed for the visualization of OSCS in Hep samples along with other natural glycosaminoglycans possibly present as "process-related impurities", in particular dermatan sulfate (DS) and chondroitin sulfate (CS). Agarose-gel electrophoresis under non-conventional conditions is able to separate OSCS from Hep with its two components, the slow-moving and fast-moving species, DS and CS by performing separation for 15 h (overnight) and under high voltage (100 mA, ∼200 V). Densitometric scanning enabled us to calculate a limit of detection of ∼0.5 μg OSCS with a linear behaviour from 0.1 to 5 μg, comparable to CS/DS. Contaminated samples from Hep manufacturers were analyzed and quantitative data were found comparable to previous studies. Due to its capacity to process many samples in a single run and to the equipment commonly available in laboratories, this analytical method would be suitable for the identification and quantification of contamination by other polysaccharides, in particular OSCS and DS, within Hep preparations and formulations.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
The adulteration of raw heparin (Hep) with a synthetic oversulfated chondroitin sulfate (OSCS) not found in nature produced in 2007-2008 a global crisis giving rise to the development of additional, new and specific methods for its quality assurance and purity.
Warum dies für die Hirudotherapie relevant ist
Diese Studie entwickelte ein Agarose-Gelelektrophorese-Verfahren zum Nachweis von übersulfatiertem Chondroitinsulfat (OSCS) und anderen natürlichen Glykosaminoglykanen wie Dermatansulfat und Chondroitinsulfat als Verunreinigungen in Heparin-Formulierungen nach der Heparin-Krise 2007–2008. Die Technik bietet eine sensitive, zugängliche Methode zur Identifizierung und Quantifizierung von Polysaccharid-Kontaminationen in Heparin-Präparationen und -Formulierungen. Das Abstract erwähnt weder Blutegel, Hirudotherapie, Hirudin noch irgendwelche aus Blutegeln gewonnenen Produkte und stellt keinen Vergleich zwischen Heparin und blutegelbasierten Antikoagulanzien an. Folglich besteht keine direkte Relevanz für den ASH-Bereich; die Arbeit konzentriert sich strikt auf pharmazeutische Qualitätskontrolle von Heparin.
Zitation
Agarose-gel electrophoresis for the quality assurance and purity of heparin formulations
Volpi N et al. · Journal of pharmaceutical and biomedical analysis, 2012
Verwandter klinischer Kontext
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