Table 3.
89Zr-panitumumab Final Product Specifications
| Test | Specification |
|---|---|
| Chemical Purity (particulates) | Clear and Colorless |
| pH | 6-8 |
| Gentistic Acid | ≤5 mg per dose |
| Chemical Purity (HPLC) | Protein <1 mg per injected dose |
| Radiochemical Purity (HPLC) | >95% |
| Radiochemical Purity (TLC) | Rf <0.5, Purity >90% |
| Radionuclidic Purity | Measured half-life 78 hours |
| Residual Solvent Levels | None |
| Bacterial Endotoxin Levels | <175 EU per dose |
| Sterility | No growth observed in 14 days; must also pass filter integrity test prior to injection |