Type of Posting: Revision Bulletin
Posting Date: 24–Oct–2008
Official Date: 24–Oct–2008
Expert Committee: Biologics and Biotechnology—Blood and Blood Products
Transferred to Accelerated Revision History section: 26–Feb–2010
In accordance with the Rules and Procedures of the Council of Experts, the Biologics and Biotechnology—Blood and Blood Products Expert Committee has revised the Protamine Sulfate Monograph to increase the concentration of the Heparin preparation test from 115 USP Heparin Units per mL to 139 USP Heparin Units per mL. This revision is in response to the change from Lot K-5 USP Heparin Sodium RS to the current Lot L0G091. This Revision Bulletin enables Protamine Sulfate manufacturers to release lots and avoid a potential drug product shortage.
This Revision Bulletin is official as of October 24, 2008, and supersedes the currently official monograph in the forthcoming print version of USP 32–NF 27. This revision will be published in print in USP 32–NF 27 First Supplement, which becomes available in February 2009.
Should you have any questions, please contact Anita Szajek, Ph.D. (301-816-8325 or aey@usp.org).