Table 9 Quality Control Data for three [68Ga]Ga-PSMA-11 validation runs (RPA)
From: Cyclotron-based production of 68Ga, [68Ga]GaCl3, and [68Ga]Ga-PSMA-11 from a liquid target
Tests | 1 | 2 | 3 | Avg & SD | Release Criteria (RPA) |
|---|---|---|---|---|---|
Radiochemical Purity (via TLC) | 99.94 | 99.99 | 99.94 | 99.96 ± 0.03 | ≥ 95% |
Radiochemical Purity (via HPLC) | 99.94 | 99.97 | 100.0 | 99.97 ± 0.03 | ≥ 95% |
pH | 5.0 | 5.5 | 5.5 | 5.3 ± 0.3 | 4.0–8.0 |
Visual Inspection | Passed | Passed | Passed | N/A | Clear, colorless, no visible particulate |
Radionuclidic Identity (t½) | 67.9 | 68.1 | 67.7 | 67.9 ± 0.20 | 62–74 min |
Endotoxin Analysis | <  1 | <  1 | <  1 | <  1 | ≤ 17.5 EU/mL |
Bubble Point (bar) | 4.1 | 4.2 | 4.1 | 4.1 ± 0.06 | ≥ 3.5 bar |
Sterility | Passed | Passed | Passed | Passed | Sterile – no growth |
RNP at EOS (Well Counter) | 99.7 | 99.8 | 99.8 | 99.8 ± 0.06 | ≥ 98% (at time of use) |