Table 6.
Stability test of injectable solution of [18F]F-PSMA-1007.
| 1 h Stability Test | ||||||||
| Parameter | Method | Acceptance Criteria |
Batch 14/02/19
Sup. 1 |
Batch 15/03/19
Sup. 1 |
Batch 12/04/19
Sup. 1 |
Batch 09/07/20
Sup. 2 |
Batch 30/07/20
Sup. 2 |
Batch 06/08/20
Sup. 2 |
| Appearance | Visual test | Clean and Colorless Solution | Complies | Complies | Complies | Complies | Complies | Complies |
| Radiochemical Purity | TLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
0.5% 99.5% |
1.2% 98.8% |
0.5% 99.5% |
0.7% 99.3°% |
0.2% 98.8°% |
0.6% 99.4% |
| Radiochemical Purity | HPLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
n.p. 98.4% |
n.p. 97.8% |
n.p. 97.7% |
n.p. 97.9% |
n.p. 98.3% |
n.p. 98.2% |
| Chemical Purity | TLC | TBA ≤ 260 µg/mL | Complies | Complies | Complies | Complies | Complies | Complies |
| pH | pH Strips | 4.8–8.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 |
| 3 h stability test | ||||||||
| Parameter | Method | Acceptance Criteria |
Batch 14/02/19
Sup. 1 |
Batch 15/03/19
Sup. 1 |
Batch 12/04/19
Sup. 1 |
Batch 09/07/20
Sup. 2 |
Batch 30/07/20
Sup. 2 |
Batch 06/08/20
Sup. 2 |
| Appearance | Visual Test | Clean and Colorless Solution | Complies | Complies | Complies | Complies | Complies | Complies |
| Radiochemical Purity | TLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
0.4% 99.6% |
1.3% 98.7% |
0.6% 99.4% |
0.8% 99.2% |
0.2% 99.8% |
0.7% 99.3% |
| Radiochemical Purity | HPLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
n.p. 98.4% |
n.p. 97.8% |
n.p. 97.7% |
n.p. 97.9% |
n.p. 98.1% |
n.p. 98.1% |
| Chemical Purity | TLC | TBA ≤ 260 µg/mL | Complies | Complies | Complies | Complies | Complies | Complies |
| pH | pH Strips | 4.8–8.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 |
| 6 h stability test | ||||||||
| Parameter | Method | Acceptance Criteria |
Batch 14/02/19
Sup. 1 |
Batch 15/03/19
Sup. 1 |
Batch 12/04/19
Sup. 1 |
Batch 09/07/20
Sup. 2 |
Batch 30/07/20
Sup. 2 |
Batch 06/08/20
Sup. 2 |
| Appearance | Visual Test | Clean and Colorless Solution | Complies | Complies | Complies | Complies | Complies | Complies |
| Radiochemical Purity | TLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
0.4% 99.6% |
1.9% 98.1% |
0.9% 99.1% |
09% 99.1% |
0.3% 99.7% |
0.8% 99.2% |
| Radiochemical Purity | HPLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
n.p.98.4% | n.p. 97.8% |
n.p. 97.7% |
n.p. 97.7% |
n.p. 98 % |
n.p. 98.1% |
| Chemical Purity | TLC | TBA ≤ 260 µg/mL | Complies | Complies | Complies | Complies | Complies | Complies |
| pH | pH Strips | 4.5–8.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 |