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Case Study: Contamination of Heparin With Oversulfated Chondroitin Sulfate

Case Study: Contamination of Heparin With Oversulfated Chondroitin Sulfate

Edward K Chess, Shawn Bairstow, Shane Donovan, Karalyn Havel, Peifeng Hu, Richard J Johnson, Sarah Lee, Jeff McKee, Reagan Miller, Edwin Moore, Mark Nordhaus, Joseph Ray, Christina Szabo, Todd Wielgos

Handb Exp Pharmacol. 2012;(207):99-125.

PMID: 22566223

Abstract:

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. The isolation and structure determination of this contaminant was accomplished by an FDA-led consortium of academic and government laboratories and independently by Baxter Healthcare, whose vial products were first identified in the USA as being associated with the adverse events. Oversulfated chondroitin sulfate was shown to produce acute hypotension in animal models, demonstrating that it was most likely the causative agent responsible for certain of the reported adverse events in patients receiving the contaminated heparin products.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
CS31041821	Heparin Sodium with Oversulfated Chondroitin Sulfate			Price
CS31042432	Oversulfated Chondroitin Sulfate			Price

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