Table 2.
Clinical level quality control test acceptance criteria routinely used at MSKCC for manual 18F-FDHT synthesis compared to results from this study.
| Clinical QC test | MSKCC acceptance criteria | Results of this study |
|---|---|---|
| Optical clarity | Clear and particle free | Clear and particle free |
| pH | 5.5–8.0 | 5.5–6.0 |
| Radiochemical purity | >95% | 98% |
| Radiochemical identity | Matches retention time of the standard | Matches retention time of the standard |
| F18 radionuclide identity | Half-life 105–115 min | 111 min |
| Endotoxin level (LAL) | < 5 EU/mL | 0.318 EU/mL |
| Filter integrity | > 50 psig | 51 psig |
| Ethanol content | < 10%(100,000 ppm) | 70,000–80,000 ppm |
| Sterility | No growth in 14 days | No growth in 14 days |