Table 4.
Stability of carmustine (Carmustin Obvius, Carmubris) infusion solutions (0.20 mg/mL, 1.00 mg/mL) diluted in 5% glucose injection solution (freeflex PP/PE bags), stored at 22°C for 11 hours 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 | 3.5 hours | 6 hours | 8.5 hours | 11 hours | |
| Carmustin Obvius | 0.2 | 0.2038 (±1.36) | 96.47 (±0.51) | 93.39 (±0.52) | 91.07 (±0.39) | 88.68 (±0.38) |
| Carmubris | 0.2045 (±1.16) | 96.08 (±0.31) | 93.57 (±0.49) | 91.36 (±0.30) | 88.88 (±0.32) | |
| Carmustin Obvius | 1.0 | 0.9855 (±1.28) | 96.41 (±0.86) | 94.59 (±0.64) | 92.14 (±0.76) | 89.99 (±0.69) |
The remaining carmustine concentration is expressed as mean±RSD percentage rate (%) of nine measurements per time point (n=9).
RSD, relative standard deviation.