Summary
A storage study of factor IX concentrate was performed on 35 randomly selected batches
that had been prepared between 1976 and 1980. Vacuum stability, dissolution time,
F IX procoagulant activity, NAPTT, and thrombin generation were measured immediately
after the manufacturing process and compared in this study with the results obtained
from the spare samples analysed in 1981. No significant changes during storage at
cold room temperature for up to 5 years were established. The product can thus be
considered to be stable for 5 years at + 4° C.
Key words
Factor IX concentrate - Stability - Shelf life - Thrombogenicity - Thrombin generation
