Abstract
The stability of thiotepa (lyophilized) 0.5 and 5 mg/mL in 5% dextrose injection was studied. Vials of lyophilized thiotepa were reconstituted 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 polyolefin bags to nominal thiotepa concentrations of 0.5 and 5 mg/mL. Triplicate test admixtures were prepared and stored at 4 or 23 °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, turbidimetry, and stability-indicating high-performance liquid chromatography. No incompatibilities were observed. Admixtures containing thiotepa 0.5 mg/mL retained at least 90% of the initial drug concentration for eight hours at either temperature in either type of container; after 24 hours, losses ranged from 10% to 17%. Thiotepa in the 5- mg/mL admixtures was stable for 3 days at 23 °C and 14 days at 4 °C in both container types. Thiotepa (lyophilized) 0.5 mg/mL in 5% dextrose injection was stable for eight hours at 4 or 23 °C. Thiotepa (lyophilized) 5 mg/mL in 5% dextrose injection was stable for 3 days at 23 °C and 14 days at 4 °C.
Original language | English (US) |
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Pages (from-to) | 2728-2730 |
Number of pages | 3 |
Journal | American Journal of Health-System Pharmacy |
Volume | 53 |
Issue number | 22 |
DOIs | |
State | Published - Nov 15 1996 |
Externally published | Yes |
Keywords
- Additives
- Antineoplastic agents
- Concentration
- Containers
- Dextrose
- Diluents
- Incompatibilities
- Injection s
- Lyophilization
- Polyolefin
- Polyvinyl chloride
- Stability
- Storage
- Temperature
- Thiotepa
ASJC Scopus subject areas
- Pharmacology
- Health Policy