Table 2 Results of three validation batches of [68Ga]Ga-PSMA-11 using eluate of two generators
Item | Time (h) | Batch 4 | Batch 5 | Batch 6 |
|---|---|---|---|---|
Age generator (weeks) | Generator 1: 2 Generator 2: 27 | Generator 1: 2 Generator 2: 28 | Generator 1: 3 Generator 2: 28 | |
Radiochemical yield (%) (Corrected for decay) | T = 0 | 96 | 99 | 101 |
Gallium-68 activity (MBq) | T = 0 | 1961 | 2018 | 2035 |
Identification (min) (Criteria: Rt68Ga-PSMA-11–Rtref = 0.4 ± 0.2 min | T = 0 | 0.38 | 0.38* | 0.38 |
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 | 4.7 | 4.6 | 4.6 |
T = 2 | 4.6 | 4.6 | 4.6 | |
T = 4 | 4.6 | 4.6 | 4.6 | |
T = 6 | 4.6 | 4.6 | 4.6 | |
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 | 0.73 | 0.96 | 1.12 |
T = 2 | 0.69 | 0.77 | 0.74 | |
T = 4 | 0.62 | 0.70 | 0.67 | |
T = 6 | 0.67 | 0.88 | 1.11 | |
Radiochemical purity (%) (Criteria: [68Ga]Ga-PSMA-11 > 95%) | T = 0 | 99.1 | –** | 98.4 |
T = 2 | 99.0 | 99.0 | 99.0 | |
T = 4 | 99.2 | 99.1 | 99.2 | |
T = 6 | 99.3 | 99.0 | 98.8 | |
Germanium-68 breakthrough (%) (Criteria: < 0.001%) | T = 0 | 0.00009 | 0.00009 | 0.00007 |