Table 3 Physicochemical quality control parameters for three consecutive batches of [11C] PiB (labelling time 1 min)
Parameter | Release criteria | 1 | 2 | 3 |
|---|---|---|---|---|
Visual inspection | Clear. colourless | Pass | Pass | Pass |
pH | 4.5–8.5 | 5.5 | 5 | 5.2 |
Radiochemical identity | Relative retention time: 0.9–1.1 | 1.02 | 1.01 | 1.00 |
Radiochemical Purity | ≥ 95% | 100 | 98.6 | 98.1 |
PIB concentration (μg/mL) | No limit stablished | 4.61 | 4.15 | 4.06 |
Molar Activity | ≥ 30 GBq/μmol | 60.3 | 62.3 | 61.6 |
Precursor concentration (μg/mL) | No limit stablished | 10.25 | 3.06 | 1.63 |
Total impurities concentration (μg/mL) | No limit stablished | 3.18 | 2.08 | 1.50 |
Residual solvents analysis | Acetone: < 0.5% | 0.006 | 0.003 | 0.056 |
Ethanol: < 10% | 7.09 | 7.57 | 7.67 | |
Acetonitrile < 0.04% | 0.004 | 0.008 | 0.005 | |
Diglyme: < 0.04% | No detected | No detected | No detected | |
PhSiH3: < 0.04% | No detected | No detected | No detected | |
Radionucledic identity (t½) | 19.9–20.9 min | 20.4 | 20.1 | 20.6 |
Radionucledic purity | > 99.5% gamma emission at 511 keV | Ok | Ok | Ok |