Table 1.
Quality control results of [18F]DHMT.
| Test | Release Criteria for Human Use | Result |
|---|---|---|
| Visual inspection (n = 9) | Clear, colorless | Clear, colorless |
| Solution pH (n = 9) | 4.5–8.5 | 7 |
| Residual solvent test (n = 1) | MeCN < 0.41 mg/mL, DMF < 0.88 mg/mL | Pass |
| K2.2.2 test (n = 1) | <0.05 mg/mL | Pass |
| Endotoxin test (n = 1) | <17.5 EU/mL | <5 EU/mL |
| Sterile filter integrity test (n = 1) | Bubble point pressure > 50 psi | Pass |
| Sterility test (n = 1) | No bacterial growth | Pass |
| Radiochemical purity (n = 9) | >90% | 96.3% ± 1.9% |
| Radionuclide identity (n = 9) | Measured t1/2 between 98.8 to 128.8 min | 110.2 ± 3.5 min |