USP Heparin Information

Last 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).

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Documentary Standards


Stage 1 Monograph Revisions

FAQs about the Heparin Monograph Revisions

Stage 2 Monograph Revisions
  • USP will be focusing Stage 2 activities on new methodologies for identification, the development of a new potency assay and tests for impurities
  • Requests for assistance:
    • Alternative Identification Tests
      • Validation packages
    • Purity Tests
    • Submission of supporting batch release data
      • Dermatan sulfate limit
      • Potency limit
      • Specific optical rotation
      • Others
    • Reference standard candidates

Reference Standards


In 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.

USP Heparin Sodium Identification RS (new) Order
USP Heparin System Suitability RS (new) Order
USP Endotoxin RS Order
USP Heparin Sodium RS Order

Download the entire USP Reference Standards Catalog.

Meetings: Latest Activity


June 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 Content


FAQs: FAQs about the Heparin Monograph Revisions

Media Information

USP's Compendial Notices

To keep informed about any Revision Bulletin to the USP Heparin monograph, sign up for USP's free Compendial Notices email service.

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Contacts


General: Angela Long, or 301-816-8382
Media: Laura Provan, or 301-816-8268
Monograph: Tina Morris, or 301-816-8397
Reference Materials: Shawn Dressman, or 301-816-8261
Reference Standards Ordering: USP Customer Service, or 800-227-8772

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