Table 4.
Acceptance criteria and average result of five [68Ga]-derivatives synthesis obtained with condition of condition 3.
| Parameters | Acceptance Criteria | Average NOTA-OncoFAP | Average NODAGA-OncoFAP | Average DOTAGA-OncoFAP |
|---|---|---|---|---|
| [68Ga]-labeled activity MBq | 200–1300 | 520–580 | 900–970 | 850–920 |
| Volume (mL) | 12 | 12 | 12 | 12 |
| Aspect | Clear colorless solution | Clear colorless solution | Clear colorless solution | Clear colorless solution |
| Half-life (min) | 62–74 | 66.8 | 66.9 | 67.1 |
| - 68Ga3+ - 68Ga colloidal - RCP |
≤2% ≤3% ≥95% |
0.1 ± 0.1% 0.8 ± 0.1% 99.1 ± 0.1% |
0.1 ± 0.1% 0.7 ± 0.1% 99.2 ± 0.1% |
0.1 ± 0.1% 0.5 ± 0.1% 99.4 ± 0.1% |
| Ethanol concentration (v/v) | <10% | 4.9% ± 0.5% | 4.8% ± 0.5% | 4.9% ± 0.5% |
| 68Ge breakthrough | <10−3% | <10−4% | <10−4% | <10−4% |
| pH | 4.0–8.0 | 5.0 ± 0.3 | 5.0 ± 0.3 | 5.0 ± 0.3 |
| Bacterial endotoxins | <175 EU/V | <6 EU/V | <6 EU/V | <6 EU/V |
| Filter integrity (psi) | ≥50 | >50 | >50 | >50 |