Regulatory Focus™ > News Articles > USP Plans to Launch Updated Heparin Standard to Ensure Safety

USP Plans to Launch Updated Heparin Standard to Ensure Safety

Posted 23 May 2012

The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.

 "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to requests from the FDA, USP has identified and plans to incorporate into the standards new and improved procedures and tighter specifications for detecting and deterring the presence of OSCS as well as improved control for protein and nucleic acid impurities."

The new standard, which still must be accepted by USP's Expert Committee, was developed in conjunction with the US Food and Drug Administration (FDA) and various pharmaceutical manufacturers after contaminated supplies of Herpain were found to contain over-sulfated chondroitin sulfate (OSCS), which is an economic adulterant.

The updated standard will be able to detect the presence of OSCS, which older standards cannot, said USP in a statement.

The standard was last updated in 2009, and is scheduled to be released in the first quarter of 2013.

Read more:

USP - Quality Standards for Heparin Further Strengthened


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