IN-VITRO STABILITY OF PORCINE FACTOR-VIII (HYATE-C(R))

The stability of porcine factor VIII (Hyate:C(R)) 30 units mL(-1), 15 units mL(-1) and 5 units mL(-1) prepared aseptically in 0.9% sodium ch loride injection was studied. Solutions were stored in plastic syringe s at room temperature and ambient light, and at body temperature prote cted from light. Samples obtained immediately after mixing and at 4, 2 4, 48 and 72 h were assayed for FVIII activity using a one-stage FVIII assay. Samples were considered stable if FVIII activity did not decli ne more than 10% compared with baseline values. Hyate:C(R) 5 units mL( -1) stored at room temperature retained FVIII activity within 90% of b aseline values for at least 24 h. When stored at body temperature, FVI II activity of Hyate:C(R) 5 units mL(-1) declined to less than 90% of baseline values within 4 h. Stability of Hyate:C(R) 15 units mL(-1) an d 30 units mL(-1) stored at room temperature was retained for at least 72 h. When Hyate:C(R) 15 units mL(-1) and 30 units mL(-1) were stored at body temperature, stability was retained for 24 h. Results of this study will permit further evaluation of Hyate:C(R) stability when adm inistered by ambulatory infusion pumps.