Table 2.
Summary of the product specifications for 50 μg PentixaFor, n ≥ 3
| Test | Acceptance criteria | [68Ga]Ga-PentixaFor |
|---|---|---|
| Radiochemical purity (radio-HPLC) | > 95% | 99.8% |
| Radiochemical purity (radio-iTLC) | > 95% | 99.7% |
| pH | 4–8.5 | 5 |
| Radioactivity concentration | > 50 MBq/ mL | 120–190 MBq/ mL |
| Radioactivity | > 150 MBq | 1080–1700 MBq (depending on amount of generators used) |
| Volume | 2–10 mL | 9 mL |
| Color | Colorless | Colorless |
| Molar radioactivity | 1-60 MBq/ nmol | 27-42.5 MBq/nmol |
| Radionuclidic purity | > 99.9% | 99.9 % |
| 68Ge breakthrough | < 0.001% | 0.0002% |
| Endotoxins | < 19.0 IE/mL | < 0.5 IE/mL |
| Stability over 4 h | > 90% | 99.9% |
| EtOH content | < 10% | ≤ 6.2% (calculated) |