Table 4. Stability of dacomitinib (DMB) under different storage conditions.
Nominal Concentrations of DMB in ng/mL | Meana | SD | RSD % | Accuracy % |
---|---|---|---|---|
Room Temp. for 8 hr | ||||
2 | 1.87 | 0.06 | 3.28 | 93.59 |
15 | 14.72 | 0.34 | 2.34 | 97.30 |
150 | 147.46 | 1.35 | 0.92 | 98.31 |
400 | 393.12 | 3.52 | 0.90 | 97.72 |
Three freeze-thaw cycles | ||||
2 | 1.82 | 0.04 | 2.45 | 91.10 |
15 | 14.29 | 0.09 | 0.62 | 95.29 |
150 | 144.21 | 4.88 | 3.39 | 96.14 |
400 | 385.87 | 2.68 | 0.69 | 96.47 |
Sored at 4 °C for 24 hr | ||||
2 | 1.83 | 0.03 | 1.57 | 91.47 |
15 | 14.22 | 0.23 | 1.64 | 94.77 |
150 | 145.71 | 2.46 | 1.69 | 97.14 |
400 | 387.12 | 4.08 | 1.05 | 96.78 |
Sored at -20 °C for 30 days | ||||
2 | 1.80 | 0.06 | 3.56 | 89.98 |
15 | 14.39 | 0.57 | 3.98 | 95.95 |
150 | 148.21 | 1.85 | 1.25 | 98.81 |
400 | 392.37 | 4.14 | 1.05 | 98.09 |
a Average of six replicates