Table 1.
Radiosynthesis results
| Quality control test | Specifications | Qual Run 1 | Qual Run 2 | Qual Run 3 |
|---|---|---|---|---|
| Appearance | Clear, colorless, no particulates | Clear, colorless, no particulates | Clear, colorless, no particulates | Clear, colorless, no particulates |
| Filter integrity | Pass | Pass | Pass | Pass |
| pH | 4.0–7.0 | 4.5 | 4.5 | 4.5 |
| Radiochemical purity (%) (HPLC) | NLT 90% * | 95.31 | 95.24 | 96.40 |
| Radiochemical purity (%) (iTLC) | NLT 90% | > 99 | > 99 | > 99 |
| Radionuclidic identity (t1/2, minutes) | 64–67 | 64.46 | 67.72 | 69.65 |
| Bacterial endotoxin levels (EU/mL) | < 8.75 EU/mL | < 1.00 EU/mL | < 1.00 EU/mL | < 1.00 EU/mL |
| Sterility (observed growth after 14 d) | No growth | No growth | No growth | No growth |
| Radiochemical identity (% difference from reference Std) by HPLC | NMT 10% * | 1.46% | 1.55% | 1.30% |
| Amount of product @ EOS | N/A | 45.8 mCi (1695 MBq) | 41.1 mCi (1521 MBq) | 44.2 mCi (1635 MBq) |
| Gallium-66 and Gallium-67 impurities @ EOS | < 2.0%* | 0.132% | 0.145% | 0.159% |
NLT not less than, NMT not more than, EOS end of synthesis
*Periodic quality indicator test