Table 1.
Quality control analytical results of [177Lu]Lu−iFAP/iPSMA nanoparticles produced under GMP conditions (results of three batches).
| Test | Specification | Method | Results |
|---|---|---|---|
| Activity per vial | 3.40 ± 0.20 GBq | Ionization chamber | 3.45 ± 0.10 GBq |
| Radioactive concentration |
170 ± 8 MBq/mL | Ionization chamber | 170 ± 5 MBq/mL |
| Specific activity | ≥0.8 GBq/mg Lu | TXRF/ Ionization chamber |
0.86 ± 0.4 GBq/mg |
| Identity of 177Lu | Main emission peaks Eϒ = 113 keV; 208 keV |
Gamma spectrometry |
Complies |
| Radionuclidic purity: 177mLu Other impurities |
≤0.02% ≤0.01% |
Gamma spectrometry |
0.009 ± 0.001% ≤0.004% |
| Chemical purity | Co, Ni ≤ 0.1 µg/GBq Cu, Pb ≤ 0.5 µg/GBq Fe, Zn ≤ 1.0 µg/GBq |
ICP-MS/ Ionization chamber |
Ni, Cu < 0.020 µg/GBq Co < 0.001 µg/GBq Pb < 0.068 µg/GBq Zn < 0.074 µg/GBq Fe < 0.152 µg/GBq |
| Lutetium content | 80–120 mg/L | TXRF | 102 ± 21 mg/L |
| pH value | 6 ± 1 | pH indicator strips | 6 |
| Radiochemical purity | >98% | Ultracentrifugation | >99% |
| Sterility test | Sterile | Sterility test [32] | Sterile |
| Bacterial endotoxin | <20EU/mL | Bacterial endotoxin test [32] | Complies |