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Factor IX Complex
»Factor IX Complex conforms to the regulations of the federal Food and Drug Administration concerning biologics (see Biologics á1041ñ).It is a sterile,freeze-dried powder consisting of partially purified Factor IXfraction,as well as concentrated Factors II,VII,and Xfractions,of venous plasma obtained from healthy human donors.It contains no preservative.It meets the requirements of the test for potency in having not less than 80percent and not more than 120percent of the potency stated on the label in Factor IX Units by comparison with the U.S.Factor IX Standard or with a working reference that has been calibrated with it.
Packaging and storage—
Preserve in hermetic containers in a refrigerator.
Expiration date—
The expiration date is not later than 2years from the date of manufacture.
Labeling—
Label it with a warning that it is to be used within 4hours after constitution,and to state 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 805
Phone Number:1-301-816-8339
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