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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 IDV-ABT20190417AV-ABT20190430AV-ABT20190508A
Batch size (GBq)12.669 GBq13.240 GBq20.890 GBq
ParametersMethodAcceptance criteriaResults
Filter integrityBubble point> 50 psiPassPassPass
AppearanceVisualClear, colorless to slightly yellowish solution; free of visible particulatesPassPassPass
pHpH indicator strip4.5–7.55.55.55.5
Residual solventsGC-FIDEthanol: <  100,000 ppm36,743 ppm50,820 ppm45,641 ppm
Acetonitrile: < 400 ppm< 10 ppm< 10 ppm< 10 ppm
HPLC-UV-radiometricDimethylformamide (DMF): < 880 ppm< 1 ppm< 1 ppm< 1 ppm
Pyridazine: < 400 ppm< 1 ppm< 1 ppm< 1 ppm
 Dose calibratorHalf-life: 105–115 min112 min109 min110 min
Radiochemical identificationHPLC-UV-RadiometrictR of [18F]AMBF3-TATE: 100 ± 10% of the reference standard100%100%100%
Radiochemical purityHPLC-UV-radiometric≥ 90%99%99%96%
Molar activityHPLC-UV-radiometric≥ 44 GBq/μmol @ EOS496 GBq/μmol251 GBq/μmol559 GBq/μmol
Ascorbic acidColorimetric assay< 20,000 mg/L1000 mg/L1000 mg/L1000 mg/L
Bacterial endotoxinsLAL test< 10.0 EU/mL< 10.0 EU/mL< 10.0 EU/mL< 10.0 EU/mL
Radionuclidic purity1Gamma spectroscopy≥ 99.5%100%100%100%
Sterility1Post-releaseSterile, no growthPassPassPass
  1. GC-FID gas chromatography flame ionization detector, tR retention time, EOS end of synthesis, LAL limulus amebocyte lysate
  2. 1These tests are done retrospectively