»Antihemophilic Factor conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile, freeze-dried powder containing the Factor VIII fraction prepared from units of human venous plasma that have been tested for the absence of hepatitis B surface antigen, obtained from whole-blood donors and pooled. It may contain Heparin Sodium or Sodium Citrate. It meets the requirements of the test for potency, by comparison with the U.S. Standard Antihemophilic Factor (Factor VIII) or with a working reference that has been calibrated with it, in containing not less than 80 percent and not more than 120 percent of the potency stated on the label, the stated potency being not less than 100 Antihemophilic Factor Units per g of protein. It meets the requirements of the test for pyrogen, the test dose being 10 Antihemophilic Factor Units per kg.
Packaging and storage Preserve in hermetic containers, in a refrigerator, unless otherwise indicated.
Expiration date The expiration date is not later than 2 years from date of manufacture, within which time it may be stored at room temperature and used within 6 months of the time of such storage.
Labeling Label it to state that it is to be used within 4 hours after constitution, that it is for intravenous administration, and that a filter is to be used in the administration equipment.