Factor IX Complex
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Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 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.
2 ADDITIONAL REQUIREMENTS
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 h after constitution, and to state that it is for intravenous administration and that a filter is to be used in the administration equipment.
