Impurity | Analytical method | PEG/MgCl2 | IEC | Commercial kit | Acceptance criteria |
---|---|---|---|---|---|
Appearance | Visual inspection | Clear, colourless | Clear, colourless | ||
A260/A280 | UV spectrophotometer | 1.98 ± 0.02 | 2.00 ± 0 | 2.10 ± 0.10 | ≥ 1.75a 1.75–1.85b |
Endotoxin (EU/mg) | LAL assay | 4.25 ± 0.40 | 5.31 ± 0.53 | 4.66 ± 0.48 | ≤ 10 EU/mga, b ≤ 40 EU/mg c |
E. coli protein (μg/mg) | ELISA | Undetectable | ≤ 1 μg/mga ≤ 10 μg/mg b < 1% c | ||
E. coli gDNA (μg/mg) | Q-PCR | 2.09 ± 0.18** | 3.45 ± 0.57* | 7.49 ± 0.07 | ≤ 2 μg /mga ≤ 10 μg/mg b < 1%c |
E. coli RNA (%) | AGE | Not visible | 10.11% | Not visible | Not visiblea, b < 1%c |
Supercoiled (%) | HPLC/AGE | 94.98% | 71.24% | 93.67% | ≥ 90%a, b ≥ 80%c |