This article is about new changes made in, widely used blood thinner, Heparin. Heparin is official in USP since year 1950 and has been revised several times since then. From the news obtained from both U.S Food and Drug Administration (FDA) and Unites States Pharmacopeia (USP) that stage 2 changes will be effective from October 1, 2009. Heparin made using the tests and reference standards in the new USP monograph will become available in healthcare facilities on or after October 8, 2009.
Heparin Ad hoc Advisory Panel was formed in 2006 to focus on development of a new potency assay. Subsequently, following reports of the prevalence of contaminated heparin products that resulted in more than 200 deaths and in response to a request from FDA to update USP monographs for Heparin Sodium and Heparin Calcium following heparin recalls in early 2008, Stage 1 revisions aimed at helping to ensure a safe Heparin supply were completed and became official via Revision Bulletins posted on USP's Web site on June 18, 2008.
The Stage 2 revisions include new methodologies for identification, the implementation of a new potency assay and additional tests for impurities. In addition, the heparin potency unit has been harmonized with the International Unit (IU).
The USP Heparin Ad hoc Advisory Panel, which reports to the USP Biologics and Biotechnology Blood and Blood Products Expert Committee (BBP EC), recommended that additional changes be implemented to further strengthen the Heparin monographs. These Stage 2 revisions were presented in Pharmacopeial Forum (PF) 35(2) March-April 2009 as proposed Interim Revision Announcements (IRAs). After public and review and comment, and subsequent recommendations by the Advisory Panel, the BBP EC approved the revisions.
Additionally, the BBP EC has made 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.
The following table summarizes the Stage 1 and 2 revisions:
Following are the links to Stage 2 Heparin Sodium Monographs and Related Monographs with Conforming Changes
References:
