STABILITY OF THIOTEPA (LYOPHILIZED) IN 5-PERCENT DEXTROSE INJECTION AT 4 AND 23 DEGREES-C

The stability of thiotepa (lyophilized) 0.5 and 5 mg/mL in 5% dextrose injection was studied. Vials of lyophilized thiotepa were reconstitut ed with sterile water for injection to yield a solution with a nominal 10-mg/mL drug concentration. The reconstituted solution was filtered and diluted in 5% dextrose injection in polyvinyl chloride and polyole fin bags to nominal thiotepa concentrations of 0.5 and 5 mg/mL. Tripli cate test admixtures were prepared and stored at 4 or 23 degrees C in normal fluorescent light. Initially and after four and eight hours and 1, 3, 7, and 14 days, samples were removed for visual evaluation, tur bidimetry, and stability-indicating high-performance liquid chromatogr aphy. No incompatibilities were observed. Admixtures containing thiote pa 0.5 mg/mL retained at least 90% of the initial drug concentration f or eight hours al either temperature in either type of container; afte r 24 hours, losses ranged from 10% to 17%. Thiotepa in the 5-mg/mL adm ixtures was stable for 3 days at 23 degrees C and 14 days at 4 degrees C in both container types. Thiotepa (lyophilized) 0.5 mg/mL in 5% dex trose injection was stable for eight hours at 4 or 23 degrees C. Thiot epa (lyophilized) 5 mg/mL in 5% dextrose injection was stable for 3 da ys at 23 degrees C and 14 days at 4 degrees C.