Table 8.
Quality Control Data for three [68Ga]Ga-PSMA-11 validation runs (UM)
| Tests | 1 | 2 | 3 | Avg & SD | Release Criteria (UM) |
|---|---|---|---|---|---|
| Radiochemical Purity (via TLC) | 99.5 | 99.4 | 99.3 | 99.4 ± 0.1 | ≥ 90% |
| Relative Retention time (via HPLC) | 1.004 | 1.005 | 1.005 | 1.0046 ± 0.0003 | RRT: 0.9–1.1 |
| pH | 7.0 | 7.0 | 7.0 | 7.0 | 4.0–8.0 |
| Visual Inspection | Passed | Passed | Passed | N/A | Clear, colorless, no visible particulate |
| Radionuclidic Identity (t½) | 67.61 | 68.45 | 67.20 | 67.75 ± 0.53 | 64.6–71.4 min |
| Endotoxin Analysis | < 2 | < 2 | < 2 | < 2 | ≤ 10.9 EU/mL |
| Bubble Point (PSI) | 51 | 52 | 53 | 52 ± 1 | ≥ 50 PSI |
| Sterility | Passed | Passed | Passed | Passed | Complies with USP< 71>a |
| RNP at EOB (MCA) | 99.8 | 99.8 | 99.8 | 99.8 | ≥ 98% (at time of use) |
aSee: USP 71 Microbiological Tests/Sterility Tests 2012