Table 3.
Summary of the product specifications for 50 μg FAPI-46, n = 3
| Test | Acceptance criteria | [68Ga]Ga-FAPI-46 |
|---|---|---|
| Radiochemical purity (radio-HPLC) | > 95% | 99.7% |
| Radiochemical purity (radio-iTLC) | > 95% | 99.9% |
| pH | 4–8.5 | 4.2 |
| Radioactivity concentration | > 50 MBq/ mL | 105–242 MBq/ mL |
| Radioactivity | > 150 MBq | 740–1700 MBq (depending on amount of generators used) |
| Volume | 2–10 mL | 7 mL |
| Color | Colorless | Colorless |
| Molar radioactivity | 1–60 MBq/ nmol | 13–30 MBq/nmol |
| Radionuclidic purity | > 99.9% | 99.9% |
| 68Ge breakthrough | < 0.001% | 0.0002% |
| Endotoxins | < 19.0 IE/mL | < 5.0 IE/mL |
| Stability over 3 h | > 90% | 99.9% |