October 1, 2009: Official Stage 2 Monographs

The second stage of USP's revisions to quality standards for the widely used blood thinner heparin became official on October 1, 2009 (see list below). The Stage 2 revisions, discussed further below, 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)). For more information on the new potency assay and effect of the change in potency assignment, please see USP Statement on Heparin Potency Unit Assignment and Harmonization with the International Standard for Unfractionated Heparin and information provided by the FDA.

Now Official: Stage 2 Heparin Sodium Monographs and Related Monographs with Confirming Changes

• Heparin Sodium and Heparin Sodium Stage 2 Monograph Commentary
• Heparin Sodium Stage 2 Monograph 
• Heparin Sodium Injection Stage 2 Monograph
• Anticoagulant Heparin Solution (posted 28–Aug–2009; official 01–Oct–2009)
• Antithrombin III Human (posted 28–Aug–2009; official 01–Oct–2009)
• Heparin Calcium (posted 28–Aug–2009; official 01–Oct–2009)
• Heparin Calcium Injection (posted 28–Aug–2009; official 01–Oct–2009)
• Heparin Lock Flush Solution (posted 28–Aug–2009; official 01–Oct–2009)
• Protamine Sulfate (posted 28–Aug–2009; official 01–Oct–2009)
• <11> USP Reference Standards (USP Heparin Sodium for Assays RS Lot F) (posted 28–Aug–2009; official 01–Oct–2009)