Antihemophilic Factor
»Antihemophilic Factor conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile,freeze-dried powder containing the Factor VIIIfraction prepared from units of human venous plasma that have been tested for the absence of hepatitis Bsurface 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 80percent and not more than 120percent of the potency stated on the label,the stated potency being not less than 100Antihemophilic Factor Units per g of protein.It meets the requirements of the test for pyrogen,the test dose being 10Antihemophilic 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 2years from date of manufacture,within which time it may be stored at room temperature and used within 6months of the time of such storage.
Labeling— Label it to state that it is to be used within 4hours after constitution,that it is for intravenous administration,and that a filter is to be used in the administration equipment.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 168
Phone Number:1-301-816-8339
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