Table 3. Quality Control Data for Process Verification Batches of [18F]FMAU.
| QC test | release criteria | batch 1 | batch 2 | batch 3 |
|---|---|---|---|---|
| radioactivity concentration at end of synthesis (mCi/mL) | 1–75 mCi/mL | 18.3838 | 8.3224 | 17.1949 |
| final product appearance | clear, colorless, and free of particulates | pass | pass | pass |
| filter membrane integrity (bubble-point test) (psi) | ≥50 psi | 63 | 63 | 62 |
| Kryptofix test | ≤50 μg/mL | pass | pass | pass |
| radiochemical identity (HPLC) | within 0.5 min of the reference standard retention time | pass | pass | pass |
| standard: 9.927 min | standard: 9.947 min | standard: 9.953 min | ||
| sample: 10.002 min | sample: 10.083 min | sample: 10.102 min | ||
| radiochemical purity (HPLC) (%) | ≥95% | 99.40 | 100.00 | 99.44 |
| chemical purity (FMAU mass, μg/mL) | ≤8.33 μg/mL | 1.6900 | 2.3075 | 4.3006 |
| total impurity (non-FMAU impurities)a | <3.6 μg/dose | 0.5775 | 1.5320 | 0.4868 |
| residual solvents (GC) (ppm) | methanol: ≤ 3000 ppm | Pass | Pass | Pass |
| acetonitrile: ≤ 410 ppm | ||||
| 1,4-dioxane: ≤ 380 ppm | ||||
| radionuclidic identity (half-life) | between 105 and 115 min | 109.5637 | 110.1338 | 109.3802 |
| radionuclidic purity (KeV) | peak value is present between 501 and 521 keV | 511.7 | 511.7 | 511.7 |
| final product pH | 4.0–7.5 | 5.0 | 5.0 | 5.0 |
| bacterial endotoxin test | ≤17.5 EU/mL with maximum dose volume 10 mL | <5 EU/mL | <5 EU/mL | <5 EU/mL |
| 14-day sterility test | absence of microbials after 14-day incubation in two kinds of media | pass | pass | pass |
a
Total impurity value includes only the unidentified impurities, i.e. non-FMAU impurities.