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. 2017 Jul 14;8(1):20–26. doi: 10.1016/j.jpha.2017.07.007

Table 4.

Assessment of stability of ceritinib.

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
a

Stability data is expressed as the mean percentage of the peak area determined at certain time relative to that at time zero.

b

Stability data is expressed as the mean percentage of the analyte concentration determined at certain time point relative to the nominal concentration (%).

c

Each concentration at each time point was assessed in triplicate.