Table 2.
Average pharmaceutical quality of Biont FDG from 2286 commercial batches
| Specification | Test method* | Limits |
|---|---|---|
| Declared activity 18F (%) | IC | 90-110 |
| 18F half-life (min) | IC | 105-115 |
| Radionuclidic purity of 18F | GS | >99.9 |
| Concentration of 2-fluoro-2-deoxy-D-glucose (mg/ml)* | HPLC | ≤0.05 |
| Concentration of Kryptofix® 222 (mg/ml)* | colorim. | ≤0.22 |
| Radiochemical purity of 2-[18F]-fluoro-2-deoxy-D-glucose, with less than 10% fraction of 2-[18F]-fluoro-2-deoxy-D-mannose (%) | HPLC | ≥95.0 |
| Radiochemical impurities of [18F] fluoride and acetylated 2-[18F]-fluoro-2-deoxy-D-glucose and 2-[18F]-fluoro-2-deoxy-D-mannose (%) | TLC | ≤5.0 |
| Concentration of glucose (mg/ml) | HPLC | ≤0.63 |
| Concentration of acetonitrile (mg/ml)**** | GC | ≤0.41 |
| Concentration of ethanol (mg/ml)**** | GC | ≤5 |
| Radionuclide impurities (%)**** | GS | <0.1% |
| Bacterial endotoxins (EU/ml)**** | LAL | <17.5 |
| Sterility**** | Ph.Eur. 2.6.1 | No CFU |
*
IC-ionisation chamber (dose calibrator), GS-gamma-ray spectrometry, GC-gas chromatography, HPLC-high-performance liquid chromatography, TLC-thin layer chromatography, LAL-Limulus Amebocytus Lysate test.
**Expanded uncertainty with the coverage factor which is equal appropriately k(α) = 2 for probability α = 0.95. ***The compliance for the maximum recommended dose V = 10 ml.
****
The result of test are appended in a due time after the production, the injection may be released for use before completion of this part of analysis.