Table 4 Correction factors of related impurities
Imp-1(μg/mL) | F1 | Imp-2(μg/mL) | F2 | AR(μg/mL) | F0 | Imp-3(μg/mL) | F3 | Imp-4(μg/mL) | F4 | Imp-5(μg/mL) | F5 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 6.41 | 0.96 | 6.26 | 1.15 | 9.52 | 1 | 9.83 | 1.01 | 6.50 | 0.94 | 5.98 | 0.60 |
2 | 12.82 | 0.97 | 12.53 | 1.13 | 19.05 | 1 | 19.66 | 1.02 | 13.01 | 0.91 | 11.95 | 0.60 |
3 | 26.70 | 1.00 | 26.10 | 1.13 | 39.68 | 1 | 40.96 | 0.99 | 27.10 | 0.89 | 24.90 | 0.63 |
4 | 40.05 | 1.02 | 39.15 | 1.11 | 59.52 | 1 | 61.44 | 1.00 | 40.65 | 0.89 | 37.35 | 0.61 |
5 | 53.40 | 1.03 | 52.20 | 1.12 | 79.36 | 1 | 81.92 | 0.99 | 54.20 | 0.89 | 49.80 | 0.60 |
RSD(%) | 3.06 | 1.31 | 1.30 | 2.42 | 2.14 | |||||||
Average | 1.00 | 1.13 | 1.00 | 0.90 | 0.61 |