Ph. Eur updates heparin reference substances

The European Pharmacopeia (Ph. Eur.)  has developed four chemical reference substances to be used alongside two new monographs for heparin calcium and heparin sodium which are due to come into force on August 1, 2010.

The first three reference substances - heparin for physico-chemical analysis; heparin sodium for NMR identification; and heparin calcium for NMR identification - were made available on July 15. The fourth - dermatan sulfate and over-sulfated chondroitin sulfate - will be available from August 1.

The Europe Directorate on the Quality of Medicines (EDQM), which publishes Ph. Eur., has been revising its heparin reference standards in the wake of the contamination of heparin products with OSCS which claimed more than 200 lives around the world in 2008.

More information is available here.


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