Type of Posting: Revision Bulletin
Posting Date: 18–Jun–2008
Official Date: 18–Jun–2008
Expert Committee: Biologics and Biotechnology—Blood and Blood Products
Transferred 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 email@example.com).
Stage 1 Heparin Monograph Revisions