Skip to main content

Table 3 Description and synthetic results of Quality control tests of [18F]LBT999 for human injection after radiosynthesis on TRACERlab FXFN and AIO modules

From: Fully automated radiosynthesis of [18F]LBT999 on TRACERlab FXFN and AllinOne modules, a PET radiopharmaceutical for imaging the dopamine transporter in human brain

Quality control tests Description of the test Release criteria QC Results of [18F]LBT999
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