DEFINITION

Antithrombin III Human is a glycoprotein, which is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII. It is obtained from human plasma of healthy donors who have been tested and shown to be free from detectable agents of infection transmissible by transfusion of blood or blood derivatives. The manufacturing steps are shown to remove or inactivate known agents of infection. If substances are used for inactivation of viruses during production, the subsequent purification procedure must be validated to demonstrate that the concentration of these substances is reduced to an acceptable level and that any residues are such as not to compromise the safety of the preparation for patients. When reconstituted in the recommended volume of diluent, the potency is NLT 25 International Units (IU)/mL. It contains 80%–120% of the potency stated on the label.