Table 3 Results and typical values of [18F]FMISO injection solution obtained with FASTlab cassettes
Specification according to Ph. Eur. monograph 2459 | [18F]FMISO specification (GE Healthcare DOC1705995) | Found with original FASTlab cassette | Found with in-house prepared FASTlab cassette | |
|---|---|---|---|---|
Radiochemical yield d.c | Not specified | ≥ 26% | 49% (n = 27) | 39% (n = 19) |
Radiochemical purity [18F]FMISO (HPLC) | ≥ 95% | > 95% | 99.9% | 99.8% |
Radiochemical purity [18F]F− (TLC) | ≤ 5% | not specified | 0.3% | 0.1% |
Content of FMISO (HPLC) | ≤ 10 µg/mL** | < 5 µg/mL | 0.3 µg/mL | 0.2 µg/mL |
Content of DH-MISO (HPLC) | ≤ 10 µg/mL** | < 5 µg/mL | 1.0 µg/mL | 0.8 µg/mL |
Highest content of single other impurity (HPLC) | ≤ 10 µg/mL** | < 5 µg/mL | 0.8 µg/mL | 2.7 µg/mL |
Total content of chemical impurities (HPLC) | ≤ 50 µg/mL** | < 10 µg/mL | 3.6 µg/mL | 6.8 µg/mL |
TBA | ≤ 260 µg/mL** | < 170 µg/mL | < 260 µg/mL | < 260 µg/mL |
Radionuclidic purity (half-life) | 1.75–1.92 h | 1.75–1.92 h | 1.84 h | 1.84 h |
Ethanol (GC–MS) | < 10% v/v | < 7.9% | 6.0% | 6.0% |
Residual solvents acetonitrile (GC–MS) | < 410 µg/mL** | < 273 µg/mL | 27 µg/mL | 26 µg/mL |
pH | 4.5–8.5 | 4.5–8.0 | 6.2* | 6.8* |
Bacterial endotoxins (LAL) | < 175 IU/mL | < 175 IU/mL | < 0.8 IU/mL | < 0.8 IU/mL |
Molar activity (HPLC) | Not specified | Not specified | 565 GBq/µmol | 588 GBq/µmol |