Data of Formulation Tested in 18F-FDG Routine Production
1:15 v/v citric acid:18F-FDG | |||
Parameter | 0.06 M | 0.05 M | 0.03 M |
Number of batches studied | 10 | 10 | 10 |
Radioactivity concentration of batches studied (MBq/mL) | 2,600–4,000 | 2,600–4,000 | 2,600–4,000 |
pH range | 5.46–5.68 | 5.51–6.22 | 5.68–6.52 |
18F-fluorodeoxymannose (median ± SD) | 0.83% ± 0.73% | 1.78% ± 0.81% | 1.94% ± 0.81% |
Pharmacopeia quality control | Passed | Passed | Passed |
pH and radiochemical purity 12 h after synthesis | Passed | Passed | Passed |