TABLE 4.
161Tb-DOTATOC Specifications Until Shelf-Life Expiration Date
| Characteristic | Test | Specification |
|---|---|---|
| Appearance | Visual inspection | Clear, colorless solution, without visible particles |
| pH | pH paper | 4–8 |
| Activity concentration | Dose calibrator | 50–370 MBq/mL |
| RCP | HPLC | ≥95% |
| 161Tb-DOTATOC identity | HPLC | Peaks at defined RT in radio- and UV chromatograms |
| Impurities and degradation products | HPLC | Each impurity ≤ 100 μg/patient dose |
| Ethanol content | GC | <10% |
| Bacterial endotoxin level | LAL test | <175 IU/20 mL |
| Filter integrity (matrix-based) | bubble point test | Bubble point > 2.75 bar |
| Shelf life | 24 h |
RT = retention time; GC = gas chromatography.