Kinevac stability after reconstitution with sodium chloride injection USP, 0.9%.
Our objective was to compare the stability of Kinevac when reconstituted with sodium chloride injection, USP, 0.9%, versus the manufacturer's recommended sterile water for injection, USP, and to determine the effects on stability of deviating from the manufacturer's recommended methods of product preparation.


METHODS
Kinevac was reconstituted with either sterile water or 0.9% sodium chloride. Triplicate high-performance liquid chromatography was performed on each vial of reconstituted sample at time zero and at time zero plus 8 h. The concentration of each sample, as measured by the peak area, was recorded at each time point. The process was repeated over 4 consecutive days.


RESULTS
Kinevac reconstituted with sterile water resulted in the recovery of 89.73% of the time zero concentration after 8 h. Kinevac reconstituted with 0.9% sodium chloride resulted in chemical stability of the injection, with 80.05% recovery of the time zero value after 8 h.


CONCLUSIONS
Kinevac is more stable when reconstituted with sterile water than when reconstituted with 0.9% sodium chloride. Kinevac should be reconstituted with sterile water for injection as per the manufacturer's instructions.
Littleton
Latisha T
LT
Department of Pharmacy, Walter Reed Army Medical Center, Washington, DC, USA. Latisha.littleton@us.army.mil
Fileta
Bader B
BB
Massey
Robert
R
Wood
Timothy I
TI
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007267:Injections; D012844:Sincalide / Q000737:chemistry*; D012965:Sodium Chloride / Q000737:chemistry*; D014867:Water
D014867:Water; D012965:Sodium Chloride; D012844:Sincalide