The potency per mg was tested and found to be 150 Units/mg.
The lyophilized protein 200IU/ml was lyophilized from a sterile solution containing 1.5% Glycine, 160mM Calcium chloride and 25mM NaCitrate and 25mM NaCl.
The plasma is collected from donors with Hepatitis B vaccinated.
Each unit of plasma has been tested for HBsAg, Anti-HIV-1/2 plus O and Anti-HCV by using the imported kits which are approved by Federal Drug Administration (FDA).
Sterile Filtered White lyophilized (freeze-dried) powder.
It is recommended to reconstitute the lyophilized Factor-VIII in sterile 18MΩ-cm H2O at a concentration of 200IU/ml, which can then be further diluted to other aqueous solutions.
Make sure that the vial has reached room temperature prior to its reconstitution, otherwise it might precipitate.
Lyophilized Factor-VIII although stable at room temperature for 1 week, should be stored desiccated between 2-8oC. Upon reconstitution Factor-VIII should be storedat 4oC.
Coagulation factor VIII, Procoagulant component, Antihemophilic factor, AHF, F8, F8C, F8B, HEMA, FVIII, DXS1253E, F8 protein.