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![]() USP Heparin InformationLast updated: June 18, 2008 Due to the prevalence of contaminated heparin products that have resulted in more than 80 deaths, 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. 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. In light of this ongoing and urgent investigation, and in the interest of transparency, USP will post information related to heparin activities on this Web page. The page will be updated whenever new information is available (sign-up here for USP's Compendial Notices service to be informed of these updates). Documentary StandardsStage 1 Monograph Revisions
FAQs about the Heparin Monograph Revisions Stage 2 Monograph Revisions
Reference StandardsIn addition to the USP Heparin Sodium RS and USP Endotoxin RS, USP has developed two new reference standards to support the new methods for identification and system suitability in the heparin monographs.
Download the entire USP Reference Standards Catalog. Meetings: Latest ActivityJune 11, 2008: Open Microphone Meeting #2
April 24-25, 2008: Heparin Ad hoc Advisory Panel Recommendations April 11, 2008: Heparin Web Meeting with Industry
Web ContentFAQs: FAQs about the Heparin Monograph Revisions Media Information
USP's Compendial NoticesTo keep informed about any Revision Bulletin to the USP Heparin monograph, sign up for USP's free Compendial Notices email service. Sign-up to ReceiveContactsGeneral: Angela Long, or 301-816-8382 Related Links |
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Copyright © 2008 The United States Pharmacopeial Convention
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