Table 1.
List of common QC testings performed for a typical PET radiopharmaceutical production
| QC testings | Typical acceptable parameters for [11C]acetate release |
|---|---|
| Appearance | Clear, colorless and particle-free |
| pH | 4.0–5.5 |
| Filter bubble point test | >30 psi |
| Radiochemical purity (HPLC) | >90% |
| Chemical mass (HPLC) | < 100 ppm |
| Chemical purity (HPLC) | >90% |
| Specific activity (HPLC) | >300 mCi/μmol at injection |
| Bacterial Endotoxin Test | Pass |
| Radionuclide half-life | 20±1 min |
| GC solvent analysis | One peak, <100 ppm citrate salts |
| Sterility | pass |