Cryoprecipitated Antihemophilic Factor
» Cryoprecipitated Antihemophilic Factor conforms to the regulations of the FDA concerning biologics (640.50 to 640.57) (see Biologics 1041). It is a sterile, frozen concentrate of human antihemophilic factor prepared from the Factor VIII-rich cryoprotein fraction of human venous plasma obtained from suitable whole-blood donors from a single unit of plasma derived from whole blood or by plasmapheresis, collected and processed in a closed system. It contains no preservative. 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 having an average potency of not less than 80 Antihemophilic Factor Units per container, made at intervals of not more than 1 month during the dating period.
Packaging and storage— Preserve in hermetic containers at a temperature of 18 or lower.
Expiration date— The expiration date is not later than 1 year from the date of collection of source material.
Labeling— Label it to indicate the ABO blood group designation and the identification number of the donor from whom the source material was obtained. Label it also with the type and result of a serologic test for syphilis, or to indicate that it was non-reactive in such test; with the type and result of a test for hepatitis B surface antigen, or to indicate that it was non-reactive in such test; with a warning not to use it if there is evidence of breakage or thawing; with instructions to thaw it before use to a temperature between 20 and 37, after which it is to be stored at room temperature and used as soon as possible but within 6 hours after thawing; to state that it is to be used within 4 hours after the container is entered; and to state that it is for intravenous administration, and that a filter is to be used in the administration equipment.
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Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Senior Scientist
(BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP32–NF27 Page 1567