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min1986
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Factor IX Complex (fak' tor). » Factor IX Complex conforms to the regulations of the federal 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 not less than 80 percent and not more than 120 percent 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 2 years from the date of manufacture. Labeling— Label it with a warning that it is to be used within 4 hours 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— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Anita Y. Szajek, Ph.D. Principal Scientific Liaison (301) 816-8325 (BIO22010) Monographs - Biologics and Biotechnology 2 USP38–NF33 Page 3434 |
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