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Revision Bulletin

Heparin Sodium and Heparin Calcium Monographs

Posted Date: June 18, 2008
Official Date: June 18, 2008
Expert Committee: Biologics and Biotechnology-Blood and Blood Products
Transfers to Accelerated Revision History section: Upon the official date of Stage 2 Heparin monographs


Due to the prevalence of contaminated heparin products, USP has revised its monographs for Heparin Sodium and Heparin Calcium. These "Stage 1" revisions to the monographs are accompanied by two new and two existing USP Reference Standards (see the Heparin Hot Topics page for complete information). USP will continue efforts to revise these two heparin drug substance and related drug product monographs in future, Stage 2 revisions. Stage 2 revisions include consideration of new methodologies for identification, the development of a new potency assay and tests for impurities.

Should you have any questions, please contact Anita Szajek at (301–816–8325 or .

Stage 1 Heparin Monograph Revisions