Highly sensitive potentiometric strip test for detecting high charge density impurities in heparin
Research article published in Analytical chemistry (2011)
Abstract
Contamination of heparin with oversulfated chondroitin sulfate (OSCS) became a matter of grave concern in the medical field after many fatal responses to OSCS tainted heparin products occurred during the 2007-2008 period. Even though standard lab-based analytical techniques such as nuclear magnetic resonance (NMR) and strong anion-exchange high performance liquid chromatography (SAX-HPLC) have proven useful for monitoring the OSCS content in heparin products, an easy-to-use, quick, portable, and cost-efficient method is still needed for on-site monitoring during and after the heparin production. In this report, a disposable strip-type electrochemical polyion sensor is described for detection of low levels of OSCS contamination in heparin. A magnetic actuator is incorporated into this simple electrode-based microfluidic device in order to create the mixing effect necessary to achieve equilibrium potential changes of the sensor within a microfluidic channel. The planar membrane electrode detector within the sample channel is prepared with a tridodecylmethylammonium chloride (TDMAC)-doped poly(vinyl chloride) (PVC) membrane essentially equivalent to previously reported polyanion-sensitive electrodes. When the concentration of heparin applied to the single-use strip device is 57 mg/mL (in only 20 μL of sample), the same concentration recommended in the NMR analysis protocol for detecting OSCS in heparin, the detection limit is 0.005 wt % of OSCS, which is ca. 20 times lower than the reported detection limit of the NMR method.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Contamination of heparin with oversulfated chondroitin sulfate (OSCS) became a matter of grave concern in the medical field after many fatal responses to OSCS tainted heparin products occurred during the 2007-2008 period.
Por qué esto importa para la hirudoterapia
Este estudio metodológico detalla el desarrollo de una prueba desechable en tira potenciométrica para detectar impurezas de sulfato de condroitina sobresulfatado (OSCS) en productos de heparina. El dispositivo utiliza un sensor electroquímico de polielectrolitos dentro de un canal microfluídico para lograr una monitorización altamente sensible in situ de la contaminación de la heparina. Esta investigación se centra exclusivamente en mejorar la seguridad y el control de calidad de la heparina farmacéutica. En consecuencia, no presenta relevancia alguna para la American Society of Hirudotherapy, ya que el estudio no involucra sanguijuelas, hirudoterapia ni anticoagulantes derivados de sanguijuelas. No se menciona el secretoma de la sanguijuela ni se realiza ningún análisis comparativo con la hirudina, por lo que cualquier conexión con las aplicaciones clínicas de las sanguijuelas está totalmente ausente del resumen.
Citación
Highly sensitive potentiometric strip test for detecting high charge density impurities in heparin
Kang Y et al. · Analytical chemistry, 2011
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026