|
Intra-batch validation (n=7) |
| |
with
IS |
without IS |
with
IS |
without IS |
with
IS |
without IS |
with
IS |
without IS |
| Nominal concentration (μg/mL) |
5.0 |
15.0 |
80.0 |
320.0 |
| Arithmetic mean (ug/mL) |
5.4 |
5.1 |
15.0 |
14.9 |
79.2 |
78.0 |
316.9 |
295.9 |
| Precision (CV%) |
9.6% |
9.2% |
8.9% |
8.2% |
1.0% |
1.8% |
2.8% |
1.5% |
| Accuracy (%) |
108.9% |
101.1% |
99.9% |
99.3% |
98.9% |
97.5% |
99.0% |
92.5% |
| Inter-batch (n=21) |
| |
with
IS |
without IS |
with
IS |
without IS |
with
IS |
without IS |
with
IS |
without IS |
| Nominal concentration (μg/mL) |
5.0 |
15.0 |
80.0 |
320.0 |
| Arithmetic mean (ug/mL) |
5.1 |
4.7 |
15.6 |
15.1 |
82.6 |
81.3 |
319.0 |
307.1 |
| Precision (CV%) |
9.4% |
10.9% |
6.9% |
6.4% |
4.6% |
5.0% |
5.5% |
6.2% |
| Accuracy (%) |
101.9% |
94.4% |
104.1% |
101.2% |
103.2% |
101.6% |
99.7% |
96.0% |
|
