Table 2.
quality control tests of 18F-FDG listed in BP
| Test | Method | Acceptance Criteria |
| Character | Not specified | Clear, colourless or slightly yellow liquid |
| Identification | Gama- Gamma-spectrum | Photon energy of 0.511Mev or 1.022MeV |
| Half-life measurement | 105 to 115 min | |
| Examine the chromatogram peak from radiochemical purity test | The product should have the same retention time as the reference solution | |
| pH | Not specified | 4.5 to 8.5 |
| Chemical Purity: | ||
| 2-FDG | HPLC | The area of the 2-FDG peak is not greater than the area of the reference peak (10mg/maximum injected dose in mL) |
| Kryptofix | Colourimetirc | The test spot should not be darker than the reference spot |
| tetra-alky ammonium salt | HPLC | The area of the product peak is not greater that the area of the reference peak (2.75 mg / maximum injected dose in mL) |
| Residual solvent: | ||
| Acetonitrile | Not specified | Less than 4.1mg per maximum dose volume injected |
| Radionuclidic purity | Gama-spectrum | Photon energy of 0.511Mev or 1.022MeV |
| measurement of half-life | 105 to 115 min | |
| Radiochemical Purity | HPLC TLC |
Not less than 95% of the total radioactivity |
| Sterility | Standard sterility test according to BP | No bacterial growth |
| Bacterial Endotoxin | Not specified | 175 international unit/maximum dose in mL |
| Radioactivity | Measurement in calibrated dose calibrator | ---- |