Table 5.
pH of carmustine (Carmustin Obvius, Carmubris) stock solution stored for 48 hours at 2–8°C in the punctured vial and carmustine infusion solutions (0.20 mg/mL, 1.00 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 | Concentration (mg/mL) | Mean±SD pH (n=3) | ||||||
| Initial | 12 hours | 24 hours | 48 hours | 60 hours | 60+3 hours | 60+6 hours | ||
| Carmustin Obvius | 3.33 | 5.91 (±0.41) | 5.76 (±0.28) | 4.84 (±0.08) | 4.62 (±0.07) | NA | ||
| Carmubris | 6.53 (±0.06) | 5.41 (±0.08) | 5.42 (±0.10) | 5.24 (±0.02) | ||||
| Carmustin Obvius | 0.2 | 6.77 (±0.13) | 6.51 (±0.05) | 6.41 (±0.06) | 6.39 (±0.08) | 6.28 (±0.02) | 6.08 (±0.07) | 6.21 (±0.19) |
| Carmubris | 6.79 (±0.10) | 6.57 (±0.10) | 6.17 (±0.22) | 6.37 (±0.12) | 5.42 (±0.15) | 5.62 (±0.09) | 4.98 (±0.15) | |
| Carmustin Obvius | 1.0 | 6.67 (±0.17) | NA | 6.08 (±0.07) | 5.57 (±0.14) | 5.55 (±0.20) | NA | |
Mean±SD pH of three measurements per sample per time point (n=3).
NA, not applicable.