Table 1 Summary of the product specifications for 50 μg FAPI-46, n = 3
QC Test | Release Criteria | Trasis (n = 3) | Scintomics (n = 3) | Synthra (n = 3) |
|---|---|---|---|---|
Yield % | N/A | 92.45% | 93.32% | 92.86% |
Visual Inspection | Clear, colorless | Clear, colorless | Clear, colorless | Clear, colorless |
Radio chemical identity | RRT* = 0.9–1.1 | 1.01 | 1.01 | 1.01 |
Radio chemical purity | > 95% | > 99.4% | > 99.7% | > 99.8% |
Dose pH | 4.0–8.0 | 6.5 | 7.5 | 7.0 |
Sterile Filter Integrity Test | > 3.2 bar | > 3.2 bar | > 3.2 bar | > 3.2 bar |
Radionuclidic Identity (t1/2) | 62–74 | 67 | 67 | 67 |
Radionuclide impurity | < 0.001% | 0.0004% | 0.0001% | 0.0001% |
Endotoxin analysis | ≤ 175 EU/ml | < 5.0 EU/ml | < 5.0 EU/ml | < 5.0 EU/ml |
Sterility Testing | No colony growth out to 14 days | pass | pass | pass |