Table 3 Description and synthetic results of Quality control tests of [18F]LBT999 for human injection after radiosynthesis on TRACERlab FXFN and AIO modules
Quality control tests | Description of the test | Release criteria | QC Results of [18F]LBT999 | |
|---|---|---|---|---|
FXFN | AIO | |||
Particulates and color | Visual inspection for color & particulates | Clear, particle-free and colorless | passed | passed |
pH | Use of pH strip test | 4–5-8.5 | 5.8 | 7 |
Radionuclidic identity | Half-life determination | 105–115 min | passed | passed |
Radionuclidic purity | Gamma spectrometer | 505-515 keV | passed | passed |
Filter integrity | Bubble point test | Meet manufacturer’s requirement | passed | passed |
Radiochemical purity | Determined by HPLC | > = 95% | > 99.2 | > 98 |
Radiochemical identity | Determined by HPLC | +/− 3% rt | passed | passed |
Radiochemical identity | Determined by Radio-TLC | > = 95% | passed | passed |
Residual Kryptofix 2.2.2 | Color spot test | < 0.22 mg/mL | passed | passed |
Na-Asc concentration | Reflectometer | 0.35–0.47% m/V | passed | passed |
Residual solvent: ACN | Determined by GC | <= 0.41 mg/ml | passed | passed |
Residual solvent: EtOH | Determined by GC | <= 100 mg/ml | passed | passed |
Bacterial endotoxin | Endosafe (Charles River) | <= 17.5 EU/dose | passed | passed |
Sterility test* | No growth observed after 14 days | No visible μorganism growth | passed | passed |