| Mixture |
Storage conditions |
Variation of pH (%) |
Remaining concentration (%) |
| Light |
T |
7 days |
15 days |
7 days |
15 days |
| 1 |
L |
F |
-6.6 |
-6.6 |
99.33 ± 1.00 |
98.53 ± 0.15 |
| 2 |
L |
RT |
-9.3 |
-10.0 |
100.20 ± 0.70 |
99.40 ± 0.50 |
| 3 |
PL |
F |
-8.7 |
- |
97.00 ± 2.00 |
- |
| 4 |
PL |
RT |
-9.9 |
- |
98.40 ± 1.30 |
- |
| 5 |
L |
F |
-12.6 |
-13.4 |
99.45 ± 1.02 |
98.30 ± 1.50 |
| 6 |
L |
RT |
-1.9 |
-1.7 |
99.09 ± 0.19 |
97.50 ± 2.40 |
| 7 |
PL |
F |
-1.1 |
- |
98.00 ± 0.40 |
- |
| 8 |
PL |
RT |
-2.9 |
- |
99.00 ± 0.60 |
- |
| 9 |
L |
F |
-1.8 |
-1.9 |
98.64 ± 0.10 |
97.00 ± 2.00 |
| 10 |
L |
RT |
-0.9 |
-1.2 |
98.30 ± 0.60 |
97.57 ± 0.06 |
| 11 |
PL |
F |
+0.4 |
- |
98.30 ± 0.30 |
- |
| 12 |
PL |
RT |
-1.2 |
- |
98.60 ± 0.30 |
- |
| R |
L |
F |
- |
- |
96.80 ± 0.90 |
74.68 ± 1.00 |
|
T: Temperature; L: Exposition to ambient light; PL: Protection from light
F: Refrigerated (4.9 ± 1.5°C); RT: Room temperature (27.0 ± 0.9°C);
R: Reconstituted |
| Table 2: Variation of pH and remaining concentration of fosaprepitant in mixtures during storage |
