Table 1 Results of three validation batches of [68Ga]Ga-PSMA-11 using eluate of one generator
Item | Time (h) | Batch 1 | Batch 2 | Batch 3 |
|---|---|---|---|---|
Age generator (weeks) | 3 | 25 | 26 | |
Radiochemical yield (%) (Corrected for decay) | T = 0 | 102 | 92 | 91 |
Gallium-68 activity (MBq) | T = 0 | 1260 | 763 | 740 |
Identification (min) (Criteria: Rt68Ga-PSMA-11–Rtref = 0.4 ± 0.2 min) | T = 0 | 0.39 | 0.39 | 0.36 |
Appearance (Criteria: clear, colourless, and without undissolved matter) | T = 0 | Complies | Complies | Complies |
T = 2 | Complies | Complies | Complies | |
T = 4 | Complies | Complies | Complies | |
T = 6 | Complies | Complies | Complies | |
pH (Criteria: pH 3.2–6.5) | T = 0 | 4.9 | 4.9 | 5.0 |
T = 2 | 4.9 | 5.0 | 4.9 | |
T = 4 | 5.0 | 5.1 | 4.9 | |
T = 6 | 5.0 | 5.1 | 5.0 | |
Sterility (Criteria: TSB clear after 14-day incubation) | Complies | Complies | Complies | |
Endotoxin (IU/mL) (Criteria: < 32 IU/mL) | < 0.050 | < 0.050 | < 0.050 | |
Non-complexed gallium-68 species (%) (Criteria: ≤ 3%) | T = 0 | 0.47 | 0.49 | 0.60 |
T = 2 | 0.47 | 0.64 | 0.58 | |
T = 4 | 0.78 | 0.52 | 0.57 | |
T = 6 | 0.82 | 0.95 | 0.97 | |
Radiochemical purity (%) (Criteria: [68Ga]Ga-PSMA-11 > 95%) | T = 0 | 99.2 | 99.3 | 99.2 |
T = 2 | 99.6 | 98.0 | 98.8 | |
T = 4 | 99.1 | 99.3 | 99.3 | |
T = 6 | 99.1 | 99.0 | 99.0 | |
Germanium-68 breakthrough (%) (Criteria: < 0.001%) | T = 0 | 0.00008 | 0.00002 | 0.00006 |