Table 1.
Quality control data from a representative synthesis run
| Determined parameter | Defined range | Found value |
|---|---|---|
| Half life | 61.2–74.8 min | 66.2 min |
| Appearance | Clear colorless | ok |
| Volume | 7–12 ml | 8.5 ml |
| Particle | Free of particle | ok |
| pH | 4.5–7.0 | 6 |
| Radiochemical purity TLC | >98 % | 99.7 % |
| Radiochemical purity HPLC | >92 % | 99.4 % |
| Identity HPLC (retention time) | 6.7–7.3 min | 7.0 min |
| Peptide amount (HPLC) | <25 μg | 14 μg |
| Sterility testa | Sterile | ok |
| 68Ge contenta | <100 Bq/ml | 0.02 Bq/ml |
| Endotoxin | <14.6 EU/ml | <0.25EU/ml |
| Ethanol content (GC)a | <10 % | 2.7 % |
aHas been carried out after release of the radiopharmaceutical