Table 1.
Summary of the product specifications and validation results for the three consecutive validation productions of [68Ga]Ga-ABY-025
| Test | Acceptance criteria | GABY18002 | GABY18003 | GABY18004 |
|---|---|---|---|---|
| Radiochemical purity | ≥ 90%; no unknown impurity corresponds to > 5% | 99 | 99 | 98 |
| Chemical purity | Absence of unknown UV signals | > 99 | > 99 | > 99 |
| pH | 4.0-8.0 | 7.4 | 7.4 | 7.4 |
| Radioactivity concentration | 5-100 MBq/mL | 35 | 40 | 49 |
| Radioactivity | 50-500 MBq | 240.8 | 290 | 350 |
| Volume | 5-10 mL | 6.79 | 7.28 | 7.18 |
| Radionuclidic purity | > 99.9% | > 99.9999 | > 99.9999 | > 99.9999 |
| 68Ge breakthrough | < 0.001% | 0.000005 | 0.000006 | 0.000004 |
| Sterility test | Sterile | Sterile | Sterile | Sterile |
| Endotoxins test | < 3 EU/mL | < 0.25 | < 0.25 | < 0.25 |
| Stability | RCP ≥ 90% within 120 min | 99 | 98 | 97 |
| Ethanol* | < 10% | 3.2 | 3.5 | 3.3 |
| Sterile filter integrity | ≥ 1 bar | Passed | Passed | Passed |
*
Determined by gas chromatography.