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.
Resumen
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.
Por qué esto importa para la hirudoterapia
Este estudio desarrolló un método de electroforesis en gel de agarosa para detectar sulfato de condroitina sobresulfatado (OSCS) y otros glicosaminoglucanos naturales como el sulfato de dermatano y el sulfato de condroitina como impurezas en formulaciones de heparina tras la crisis de la heparina de 2007-2008. La técnica ofrece una forma sensible y accesible de identificar y cuantificar la contaminación polisacárida en preparados y formulaciones de heparina. El resumen no menciona sanguijuelas, hirudoterapia, hirudina ni ningún producto derivado de sanguijuela, y no realiza ninguna comparación entre la heparina y los anticoagulantes basados en sanguijuelas. En consecuencia, no existe relevancia directa para el ámbito de la ASH; el trabajo se centra estrictamente en el control de calidad farmacéutica de la heparina.
Citación
Agarose-gel electrophoresis for the quality assurance and purity of heparin formulations
Volpi N et al. · Journal of pharmaceutical and biomedical analysis, 2012
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026