Recent Adulteration of Heparin Drives Newly Proposed USP Standards

This month the U.S. Pharmacopeia (USP) proposed a second revision to their standards for the blood thinner, Heparin. This measure is to increase patient safety particularly because adulterated heparin resulted in the reported deaths of more than 200 patients worldwide in 2007 - 2008.

Most standards tests are generated to ensure manufacture quality and not equipped to look at unknown contaminants that may be added deliberately—as was the case with heparin. In the recent heparin recall the drug was adulterated with over-sulfated chondroitin sulfate and was not detected by current methods available then.

While we applaud the USP for answering this new threat to our citizen’s health, it does indicate that our pharmaceutical security measures need to be more proactive rather than reactive. Current science now offers methods to scan products to alert the user of unknown contaminants through the use of EDXRD technology. For more information on this revolutionary solution, visit: www.xstreamsystems.net.

To read more on the proposed USP revisions visit: http://www.usp.org/pdf/EN/aboutUSP/heparinStatement.pdf

For more information on specific changes to the monograph standards, visit www.usp.org or contact mediarelations@usp.org.