Table 6.
Specifications and analytical methods for the quality control of [18F]FE-PE2I.
| Test | Specifications | Analytical Methods |
|---|---|---|
| Identification of [18F]FE-PE2I | Radioactive half-life: 105–115 min Gamma spectrum shows only the 511 and 1022 keV peaks. The labeled product corresponds in RT to an authentic reference standard of FE-PE2I |
T1/2 measurement using a dose calibrator Gamma spectrum using a NaI well counter Product ID using HPLC |
| Radioactivity | 0.2–20 GBq at EOS | Dose calibrator |
| Volume | 32 ± 1 mL | Visual check |
| Appearance | Clear and colorless solution free from visible particulates or cloudiness | Visual inspection |
| pH | 4.0–5.0 | pH-meter |
| Residual Kryptofix | < 0.075 mg/mL | Color spot test |
| Free [18F]fluoride | ≤ 5% | HPLC with a radiodetector |
| Other 18F-labeled impurities | ≤ 5% | HPLC with a radiodetector |
| Radiochemical purity (at EOS) |
≥ 96% | HPLC with a radiodetector |
| Radiochemical purity after 6 h (end of the shelf life) | ≥ 90% | HPLC with a radiodetector |
| FE-PE2I content | ≤ 1.00 µg/mL | HPLC (UV, 220 nm) |
| Specified impurity (HPLC, RT of 3.4 min) | ≤ 1.00 µg/mL | HPLC (UV, 220 nm) |
| Total unspecified organic impurities | ≤ 1.00 µg/mL | HPLC (UV, 220 nm) |
| Total FE-PE2I and organic impurities | ≤ 1.00 µg/mL(maximum injected dose of 10 µg) | HPLC (UV, 220 nm) |
| Radionuclidic purity | ≥ 99.9% (< 0.1% radionuclidic impurities) | Gamma spectrum using an HPGe detector after the complete decay of fluorine-18 (minimum 48 h after EOS) |
| Ethanol | 3–7% (w/v) | Gas chromatography |
| Acetonitrile | ≤ 273 ppm | Gas chromatography |
| Methanol | ≤ 2000 ppm | Gas chromatography |
| DMSO | ≤ 3333 ppm | Gas chromatography |
| Microbiology | Passes the test for sterility (Ph. Eur.) | Test for sterility (Ph. Eur.), filtration method |
| Bacterial endotoxins | ≤ 0.5 EU/mL | Quantitative LAL analysis (Ph. Eur.) |
| Microbiology | Bioburden: < 10 CFU/100 mL | Membrane filtration and media growth |