Table 4.
Condition | Ceritinib stability (%) | |
---|---|---|
Bench-top stability (in stock solution) (25 °C)a | 1 µMc | 100 µMc |
1.0 h | 103.5 | 102.0 |
2.0 h | 106.9 | 108.1 |
4.0 h | 106.2 | 101.2 |
6.0 h | 108.8 | 101.1 |
Bench-top stability (in plasma) (25 °C)a | 0.003 µMc | 1.6 µMc |
1.0 h | 100.0 | 99.3 |
2.0 h | 105.4 | 101.2 |
4.0 h | 102.2 | 99.3 |
6.0 h | 104.3 | 99.5 |
Auto-sampler stability (in the precipitation solution) (4 °C)a | 0.003 µMc | 1.6 µMc |
1.0 h | 103.5 | 100.0 |
3.0 h | 104.7 | 100.2 |
6.0 h | 101.2 | 100.3 |
9.0 h | 100.0 | 100.5 |
Freeze-thaw stability (in plasma) (− 80 °C)b | 0.003 µMc | 1.6 µMc |
Cycle 1 | 107.1 | 99.0 |
Cycle 2 | 105.9 | 96.8 |
Cycle 3 | 104.7 | 98.7 |
Long-term stability (in plasma) (− 80 °C)b | 0.003 µMc | 1.6 µMc |
1 months | 105.9 | 89.7 |
5 months | 108.2 | 80.7 |
8 months | 101.2 | 83.6 |
Stability data is expressed as the mean percentage of the peak area determined at certain time relative to that at time zero.
Stability data is expressed as the mean percentage of the analyte concentration determined at certain time point relative to the nominal concentration (%).
Each concentration at each time point was assessed in triplicate.