Table 3 Quality control (QC) of [18F]AmBF3-TATE injection solution from three individual validation runs
From: Pharmacokinetics, radiation dosimetry, acute toxicity and automated synthesis of [18F]AmBF3-TATE
Run ID | V-ABT20190417A | V-ABT20190430A | V-ABT20190508A | ||
|---|---|---|---|---|---|
Batch size (GBq) | 12.669 GBq | 13.240 GBq | 20.890 GBq | ||
Parameters | Method | Acceptance criteria | Results | ||
Filter integrity | Bubble point | > 50 psi | Pass | Pass | Pass |
Appearance | Visual | Clear, colorless to slightly yellowish solution; free of visible particulates | Pass | Pass | Pass |
pH | pH indicator strip | 4.5–7.5 | 5.5 | 5.5 | 5.5 |
Residual solvents | GC-FID | Ethanol: < 100,000 ppm | 36,743 ppm | 50,820 ppm | 45,641 ppm |
Acetonitrile: < 400 ppm | < 10 ppm | < 10 ppm | < 10 ppm | ||
HPLC-UV-radiometric | Dimethylformamide (DMF): < 880 ppm | < 1 ppm | < 1 ppm | < 1 ppm | |
Pyridazine: < 400 ppm | < 1 ppm | < 1 ppm | < 1 ppm | ||
Dose calibrator | Half-life: 105–115 min | 112 min | 109 min | 110 min | |
Radiochemical identification | HPLC-UV-Radiometric | tR of [18F]AMBF3-TATE: 100 ± 10% of the reference standard | 100% | 100% | 100% |
Radiochemical purity | HPLC-UV-radiometric | ≥ 90% | 99% | 99% | 96% |
Molar activity | HPLC-UV-radiometric | ≥ 44 GBq/μmol @ EOS | 496 GBq/μmol | 251 GBq/μmol | 559 GBq/μmol |
Ascorbic acid | Colorimetric assay | < 20,000 mg/L | 1000 mg/L | 1000 mg/L | 1000 mg/L |
Bacterial endotoxins | LAL test | < 10.0 EU/mL | < 10.0 EU/mL | < 10.0 EU/mL | < 10.0 EU/mL |
Radionuclidic purity1 | Gamma spectroscopy | ≥ 99.5% | 100% | 100% | 100% |
Sterility1 | Post-release | Sterile, no growth | Pass | Pass | Pass |