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The US Pharmacopeial (USP) Convention has announced that revised monographs for heparin sodium and heparin calcium in the US Pharmacopeia (USP) are now available and official on the USP website.
The revised monographs are accompanied by two new and two updated official USP Reference Standards. These public standards allow any party – and particularly the Food and Drug Administration and manufacturers – to test heparin sodium and calcium drug substances to assure their quality.
All drug manufacturers who market heparin in the US are required to meet these newly revised standards. The heparin monographs were updated in the interest of public health following the deaths of more than 200 people earlier this year.
These deaths are suspected to have resulted from the adulteration of the blood thinner with over-sulphated chondroitin, which is derived from the chemical chondroitin and used in dietary supplements.
USP co-sponsored a meeting June 19-20, 2008, in Strasbourg, France, with the European Directorate for the Quality of Medicines (the organisation that elaborates the European Pharmacopoeia) and the UK’s National Institute for Biological Standards and Control as part of a coordinated, worldwide effort to assure the quality and purity of heparin.
“The expedited revision of USP’s heparin standards gives manufacturers, health care practitioners and patients increased confidence that this widely used drug is free of this adulterant,” said Roger L Williams, MD, USP executive vice president and chief executive.
“Absolutely yes. I want to stress to you a revision on HIT syndromes concerning heparin (every kind, not only sodium!)” – Giorgio Oriani, Italy
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