Table 3.
Stability of carmustine (Carmustin Obvius, Carmubris) stock solution stored for 48 hours at 2–8°C in the punctured vial and carmustine infusion solutions (0.2 mg/mL, 1.0 mg/mL) diluted in 5% glucose injection solution (freeflex PP/PE bags) stored at 2–8°C for 60 hours±further 6 hours stored at 22°C under light protection
| Carmustine-containing medicinal product | Initial carmustine concentration (mg/mL)±RSD (%) |
% Initial carmustine concentration remaining±RSD (%) (n=9) Measured concentration 0 hour=100% |
||||||
| Nominal | Measured | 12 hours | 24 hours | 48 hours | 60 hours | 60+3 hours | 60+6 hours | |
| Carmustin Obvius | 3.33 | 3.3707 (±0.57) | 98.46 (±1.52) | 96.87 (±1.11) | 94.02 (±2.31) | NA | ||
| Carmubris | 3.3481 (±0.93) | 99.61 (±0.68) | 97.89 (±0.47) | 95.45 (±0.76) | ||||
| Carmustin Obvius | 0.2 | 0.2011 (±1.39) | 96.84 (±0.60) | 95.42 (±0.39) | 93.03 (±0.22) | 91.95 (±0.40) | 89.82 (±0.49) | 86.80 (±0.29) |
| Carmubris | 0.1994 (±0.77) | 97.79 (±0.28) | 96.04 (±0.29) | 93.81 (±0.25) | 92.57 (±0.42) | 91.76 (±1.78) | 88.70 (±0.35) | |
| Carmustin Obvius | 1.0 | 0.9649 (±1,00) | NA | 96.39 (±0.83) | 95.47 (±0.56) | 93.07 (±0.67) | NA | |
The remaining carmustine concentration is expressed as mean±RSD percentage rate (%) of nine measurements per time point (n=9).
NA, not applicable; RSD, relative standard deviation.