Table 2 Summary data of three consecutive validation batches of [68Ga]68Ga-DOTA-ECL1 (20 μg)
Test | Batch 1 | Batch 2 | Batch 3 | Acceptance criteria |
|---|---|---|---|---|
Radiochemical purity (Radio-UV-HPLC) | 100% | 100% | 100% | > 95% |
Radiochemical purity (Radio-TLC) | 100% | 100% | 100% | > 95% |
pH | 4–8.5 | 7 | 7 | 4–8.5 |
Radiochemical yield (n.d.c.) | 63.00% | 63.00% | 66.00% | > 40% |
Radioactivity concentration | 75.6–52.48 | 75.6–52.48 | 79.2–54.98 | > 50 MBq/mL |
Radioactivity | 756–524.79 | 756–524.79 | 792–549.78 | > 150 MBq |
Volume | 10 | 10 | 10 | 2–10 mL |
Color | Colorless | Colorless | Colorless | Colorless |
Molar activity | 42.89 GBq/µmol | 42.89 GBq/µmol | 44.94 GBq/µmol | 1–60 GBq/µmol |
Radionuclidic purity | 100% | 100% | 100% | > 99.9% |
Ge-68 breakthrough | 0.00000035% | 0.00000033% | 0.00000035% | < 0.001% |
EtOH amount | 3.73% | 3.69% | 3.43% | < 10% (V/V) (< 2.5 g) |
HEPES content | 9.45 μg/mL | 9.45 μg/mL | 9.45 μg/mL | Less than 200 µg/V of HEPES in test solution |
Endotoxins | < 17.5 IU/mL | < 17.5 IU/mL | < 17.5 IU/mL | < 17.5 IU/mL |
Sterility test | Sterile | Sterile | Sterile | Sterile |
Stability over 3 h (RCP%) | 100% | 100% | 100% | > 95% |