Case study: contamination of heparin with oversulfated chondroitin sulfate.

In late 2007 and early 2008, a cluster of adverse events in patients receiving Heparin Sodium Injection occurred in the United States and in some countries in Europe. The adverse events were reported as being "allergic type" reactions, chiefly characterized by acute hypotension, nausea, and shortness of breath. The root cause of the cluster of adverse events was determined to be a contamination of the heparin by oversulfated chondroitin sulfate.

Determination of impurities in heparin by capillary electrophoresis using high molarity phosphate buffers.

Oversulfated chondroitin sulfate (OSCS), an impurity found in some porcine intestinal heparin samples was separated from intact heparin by capillary electrophoresis (CE) using a 600mM phosphate buffer, pH 3.5 as the background electrolyte in a 56cm x 25microm i.d.