DEFINITION

Factor IX Complex conforms to the regulations of the Food and Drug Administration concerning biologics (see Biologics 〈1041〉). It is a sterile, freeze-dried powder consisting of partially purified Factor IX fraction, as well as concentrated Factors II, VII, and X fractions, of venous plasma obtained from healthy human donors. It contains no preservative. It meets the requirements of the test for potency in having NLT 80% and NMT 120% of the potency stated on the label in Factor IX Units by comparison with the US Factor IX Standard or with a working reference that has been calibrated with it.