Antithrombin III (Human), THROMBATE III® is a sterile,
nonpyrogenic, stable, lyophilized preparation
of purified human antithrombin
THROMBATE III is prepared from pooled units of human
plasma from normal donors by
modifications and refinements of the cold
of Cohn.1 When reconstituted with Sterile Water for Injection,
USP, THROMBATE III has a pH of
6.0-7.5, a sodium content of
110-210 mEq/L, a chloride
content of 110-210 mEq/L, an alanine
content of 0.075-0.125 M and a heparin
content of not more than 0.004 unit/IU AT-III. THROMBATE III contains
no preservative and must be administered
by the intravenous route.
In addition, THROMBATE III has
been heat-treated in solution
at 60°C ± 0.5°C for not less than 10 hours.
Each vial of THROMBATE III contains
the labeled amount of antithrombin III in international units (IU) per
vial. The potency assignment
has been determined with a standard
calibrated against a World Health Organization (WHO) antithrombin
III reference preparation.