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12:00 AM
Feb 23, 2009
 |  BioCentury  |  Regulation

Analytics behind the times

The subterfuge used to contaminate the global heparin supply was possible only because the standards used to test for heparin purity were based on outmoded technology, and highlights the lack of any systematic process for updating protocols for testing drugs.

Whoever decided to save money by diluting heparin with a cheaper chemical cousin - oversulfated chondroitin sulfate - knew that OSCS could pass the standard United States Pharmacopeia (USP) tests mandated by FDA and other regulatory authorities to assure heparin's purity and quality.

The fatal chemical contaminant escaped detection because it "was engineered to pass the U.S. Pharmacopeia tests," said Janet Woodcock, director of FDA's Center for Drug...

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