Table 2 Product release specifications and validation test results of [18F]MC225
QC test | Release criteria* | Run 1 | Run 2 | Run 3 |
|---|---|---|---|---|
Visual inspection | Clear, colorless to slightly yellow solution, free of particulate matter | Pass | Pass | Pass |
Radiochemical identity | Retention time of [18F]MC225 peak within ± 10% min compared with the retention time of the known reference MC225 peak | 7.1% | 4.4% | 4.3% |
Radionuclide identity by 511 keV peak | Peak energy of gamma ray spectrum at 511 keV | Pass | Pass | Pass |
Radionuclide identity by half-life determination | 105–115 min | 110 min | 108 min | 115 min |
Content of ethanol | ≤ 10% (v/v) | 7.3% | 6.7% | 6.6% |
Residual acetonitrile | ≤ 410 μg/mL | 36.8 μg/mL | 75.4 μg/mL | 121.7 μg/mL |
Residual dimethylformamide | ≤ 880 μg/mL | N.D. | N.D. | N.D. |
Residual o-dichlorobenzene | ≤ 25 μg/mL | 9.35 μg/mL | 5.41 μg/mL | 3.86 μg/mL |
Content of MC225 | ≤ 10μg/dose | 0.5 μg/dose | 0.6 μg/dose | 0.9 μg/dose |
Total content of MC225 and related impurities | ≤ 10μg/dose | 5.4 μg/dose | 6.2 μg/dose | 3.3 μg/dose |
pH | 6.0 to 8.5 | 6.2 | 6.2 | 6.3 |
Radiochemical purity at release | ≥ 90% | 98.7% | 99.2% | 99.6% |
Molar activity at end of synthesis | N/A | 1613 GBq/μmol | 2002 GBq/μmol | 1112 GBq/μmol |
Residual K.222 | ≤ 40 μg/mL | Pass | Pass | Pass |
Bacterial endotoxins | < 150 EU/vial | < 48.5 EU | < 53.3 EU | < 51.3 EU |
Sterility testing | No growth observed in 14 days | Pass | Pass | Pass |
Filter integrity by bubble point testing | ≥ 40 psi | 48 psi | 44 psi | 44 psi |