Revision Bulletin

Anticoagulant Heparin Solution
Antithrombin III Human
Heparin Calcium
Heparin Calcium Injection
Heparin Lock Flush Solution
Protamine Sulfate
<11> USP Reference Standards

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Biologics and Biotechnology-Blood and Blood Products USP is making conforming changes to the following monographs: Anticoagulant Heparin Solution, Antithrombin III Human, Heparin Calcium, Heparin Calcium Injection, Heparin Lock Flush Solution and Protamine Sulfate. As part of the Stage 2 revisions to the Heparin Sodium monograph, USP has adopted a new potency assay for heparin, the chromogenic anti-factor IIa test. The high specificity of this assay provides an additional safeguard against potential adulterants that may display heparin-like activity in the current USP plasma-based assay. Transition to the new assay and parallel introduction of a new potency reference standard, USP Heparin Sodium for Assays Reference Standard (RS), has prompted USP to align all heparin monographs with the newly revised Heparin Sodium monograph. The new potency RS has been added to General Chapter <11> Reference Standards.

These Revision Bulletins replace current USP Heparin Sodium RS with the new USP Heparin Sodium for Assays RS for Anticoagulant Heparin Solution, Antithrombin III Human, Heparin Calcium, Heparin Calcium Injection and Heparin Lock Flush Solution. An extensive revision for USP Protamine Sulfate monograph is planned in the near future. In the interim, the Assay for USP Protamine Sulfate will continue to utilize current USP Heparin Sodium RS as well as Plasma preparation which has been moved from Heparin Sodium monograph to Protamine Sulfate monograph.

The Revision Bulletins for Anticoagulant Heparin Solution, Antithrombin III Human, Heparin Calcium, Heparin Calcium Injection, Heparin Lock Flush Solution, Protamine Sulfate supersedes those in USP 32–NF 27. The Revision Bulletin text will be incorporated into the First Supplement to USP 33–NF 28.

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

Download the Heparin Monographs below:

• Anticoagulant Heparin Solution  (86KB)
• Antithrombin III Human  (97KB)
• Heparin Calcium  (93KB)
• Heparin Calcium Injection  (101KB)
• Heparin Lock Flush Solution  (86KB)
• Protamine Sulfate  (90KB)
• <11> USP Reference Standards (Heparin Sodium for Assays Lot F)  (79KB)