Table 2.
Summary of the product specifications and results*
| Test | Acceptance criteria | [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 |
|---|---|---|
| Radiochemical purity | > 90%; no unknown impurity corresponds to > 5% | 96.9±0.6** |
| pH | 4-8.5 | 6.0 |
| Radioactivity concentration | 5-100 MBq/ml | 73.6±1.4 |
| Radioactivity | 50-500 MBq | 444±9 |
| Volume | 2-10 ml | 6.039±0.013 |
| Color | colorless | colorless |
| Specific radioactivity | 1-150 MBq/nmol | 53±10 |
| Radionuclidic purity | > 99.9% | 99.99999±0.000006 |
| 68Ge breakthrough | < 0.001% | 0.000014±0.000006 |
| Stability | RCP*** > 91% within 120 min | 96.8±0.5 |
| EtOH content | < 10% | 5.44±0.12 |
*
The results are presented as mean ± SD (n = 3-5).
**
The radiochemical purity considers the combined values for the intact and oxidized products, where 5.5±0.8% corresponded to the oxidized product.
***
RCP: radiochemical purity.