USP Standards for Unfractionated Heparin
On October 1, 2009, the implementation of the new USP monograph for unfractionated heparin went into effect. The purpose of the USP monograph changes are to further assure the purity of the Active Pharmaceutical Ingredient (API) through specific assay tests and calibrate activity to align with the International Standard (IS) issued by the World Health Organization (WHO).
As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, Fresenius Kabi USA, LLC has always met or exceeded USP standards and has successfully implemented the new USP standards. In order for customers to clearly differentiate product tested using the new USP standards, Fresenius Kabi USA, LLC has incorporated an "N" (for "new") after the expiration date on every vial. An example of the new vial label pictured here can also be viewed by clicking on the link to the New Vial Label within this section.