Table 4.
Recommended test for the quality controls and pre/post-release time schedule.
| Parameter | Method | Acceptance Criteria | Pre/Post Release |
|---|---|---|---|
| [18F]F-PSMA-1007 Activity | Dose calibrator | 7000–18,200 MBq | pre |
| Radioactive concentration | Dose calibrator | 300–791 MBq/mL | pre |
| Volume | 23 mL | pre | |
| Appearance | Visual test | Clear and colorless solution | pre |
| Identification | γ-spectrometry | Peaks at 0.511 Mev and 1.022 Mev | pre |
| Half-life | 105–115 min | pre | |
| Identification | HPLC | TR [18F]F-PSMA-1007 ± 0.5 min TR PSMA-1007 reference standard | pre |
| Radiochemical Purity | TLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
pre |
| Radiochemical Purity | HPLC | [18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95% |
pre |
| Chemical Purity | HPLC | PSMA-1007 ≤ 0.1 mg/Vmax Sum of impurities ≤ 0.5 mg/Vmax |
pre |
| TLC | TBA ≤ 260 μg/mL | pre | |
| Ethanol | GLC | ≤10% P/V | pre |
| DMSO | GLC | ≤5000 ppm | pre |
| pH | pH strips | 4.8–8.5 | pre |
| Filter Integrity | Bubble Point Test | ≥50 psi | pre |
| Radionuclidic Purity (Impurities > 2 h Half Life) |
γ-Spectrometry | ≤0.1% | post |
| Sterility | Sterility Test (Eur.Ph.) | Sterile | post |
| Bacterial Endotoxins | Eur.Ph. | ≤175 EU/V | pre |