68Ga-DOTATATE Release Specifications
| Test | Release criterion |
| Appearance of final product | Clear with no visible impurities |
| Filter test | >45 psi |
| pH | 3.0–5.5 |
| Radiochemical purity | >90% (achieved >95%) |
| Endotoxin level | <17.5 Endotoxin units per mL |
| Radionuclidic purity | Within ±90 s of 68Ga half-life |