Table 2.
Summary of syntheses and QC of [68Ga]Ga-FAPI-46.
| Parameter | Product Specification | Generator-Produced (n = 4 ± SD) |
Cyclotron-Produced (n = 3 ± SD) |
|---|---|---|---|
| Start activity (GBq) | Not specified | 0.99 ± 0.16 | 9.8 ± 0.26 |
| Precursor mass (µg) | Not specified | 50 | 50 |
| Product activity/batch (GBq) | Not specified | 0.58 ± 0.09 | 5.58 ± 0.35 |
| Activity concentration (MBq/mL) | Not specified | 60.5 ± 10.5 | 602 ± 45 |
| Non-decay-corrected RCY (%) | Not specified | 58.2 ± 3.2 | 57.0 ± 2.5 |
| AMA (GBq/µmol) | Not specified | 10.0 ± 1.7 | 98.8 ± 6.2 |
| Appearance | Clear or slightly yellow. Free of particles | Conforms | Conforms |
| pH | 4.0–8.0 | 5.3 ± 0 | 5.3 ± 0.3 |
| Product identity [68Ga]Ga-FAPI-46 | |RtRD –RtUV| < 60 s | 40 ± 9.8 | 31 ± 9.5 |
| Total chemical purity (µg/mL) | ≤10 µg/mL | ≤10 | ≤10 |
| Radiochemical impurity, B (%) | ≤3% | 0.2 ± 0.4 | 0.26 ± 0.05 |
| Total radiochemical purity (%) RCPTot = (100 − B) × T |
≥91% | 98.3 ± 0.01 | 9 7.4 ± 0.81 |
| Filter integrity (bar) | ≥3.5 bar | 4.2 ± 0.0 * | 4.1 ± 0.06 |
| Bacterial endotoxins (EU/mL) | <17.5 EU/mL | <5.0 | <5.0 |
| Ethanol (%) | <10% | 6.4 ± 0.45 | 6.8 ± 0.26 |
| Sterility | Sterile, 0 CFU | Sterile | Sterile ** |
| Radiochemical stability **** | RCPTot ≥ 91% | 95 ± 0.02 | 96 ± 1.5 *** |
Abbreviations: RCY = radiochemical yield; Rt = retention time; RD = radiodetector; UV = ultraviolet detector; B = percentage of radioactivity due to impurity [68Ga]-ions or -colloids in TLC analysis; T = proportion of the radioactivity due to [68Ga]Ga-FAPI-46 in the HPLC analysis; RCPTot = Total radiochemical purity; * based on 3 batches; ** based on one batch; *** based on 2 batches; **** Stability was 3 h EOS for generator-produced and 4 h for cyclotron-produced.