USP Updates Heparin Sodium Monograph

September 13, 2012
Susan Haigney

Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, susan.haigney@ubm.com.

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin.

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.

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