Table 4.
Stability | Quality control | PIO |
TLM |
||||||
---|---|---|---|---|---|---|---|---|---|
Meanfound(ng/mL) | SD | % CV | Accuracy % | Mean found (ng/mL) | SD | % CV | Accuracy% | ||
Immediate injection | LQC | 14.84 | 0.46 | 3.11 | 98.93 | 14.76 | 0.80 | 5.43 | 98.40 |
MQC | 4542.00 | 197.66 | 4.35 | 100.93 | 4716.00 | 192.69 | 4.09 | 104.80 | |
HQC | 7988.00 | 404.31 | 5.06 | 99.85 | 7876.00 | 404.51 | 5.14 | 98.45 | |
In-injector stability (6 h) | LQC | 14.36 | 0.32 | 2.23 | 95.73 | 14.10 | 0.67 | 4.78 | 94.00 |
MQC | 4300.00 | 132.48 | 3.08 | 95.56 | 4584.00 | 182.02 | 3.97 | 101.87 | |
HQC | 7626.00 | 418.49 | 5.49 | 95.33 | 7472.00 | 326.53 | 4.37 | 93.40 | |
Short-term stability (8 h at room temperature) | LQC | 14.48 | 0.48 | 3.29 | 96.53 | 15.00 | 0.91 | 6.06 | 100.00 |
MQC | 4156.00 | 244.70 | 5.89 | 92.36 | 4178.00 | 144.98 | 3.47 | 92.84 | |
HQC | 7914.00 | 345.59 | 4.37 | 98.93 | 7788.00 | 457.02 | 5.87 | 97.35 | |
Freeze-thaw (three freeze-thaw cycles) | LQC | 14.84 | 0.66 | 4.46 | 98.93 | 14.42 | 1.06 | 7.33 | 96.13 |
MQC | 4346.00 | 142.93 | 3.29 | 96.58 | 4462.00 | 135.54 | 3.04 | 99.16 | |
HQC | 7666.00 | 220.64 | 2.88 | 95.83 | 7976.00 | 428.05 | 5.37 | 99.70 | |
Long-term stability (7 days at −20 °C) | LQC | 13.80 | 0.64 | 4.67 | 92.00 | 14.28 | 1.28 | 8.93 | 95.20 |
MQC | 4054.00 | 252.15 | 6.22 | 90.09 | 3992.00 | 196.39 | 4.92 | 88.71 | |
HQC | 7724.00 | 429.57 | 5.56 | 96.55 | 7586.00 | 293.48 | 3.87 | 94.83 |
% CV: coefficient of variation. Accuracy: (Mean assayed concentration – nominal concentration)/(nominal concentration) ×100.