TABLE 5.
Final Product Specifications
| Test | Test method | Acceptance criteria |
| Prerelease | ||
| Radiochemical purity | Thin-layer chromatography | ≥90% |
| Appearance | Visual observation | Clear solution, free of particulates |
| pH | pH paper | 4.0–7.0 |
| Endotoxin content | PTS Endosafe, USP < 85 > | <17.5 EU/mL |
| Radiochemical identity | Thin layer chromatography* | UCLA: Rf value = 0.75–0.95 |
| UCLA: Rf value = 0.3–0.6 | ||
| Radionuclidic identity | Half-life determination | 64.4–71.2 min |
| Filter integrity | Bubble point pressure reading, USP < 823 > / < 797 > | >50 psi |
| Postrelease | ||
| Sterility | Direct inoculation. USP < 71 > / < 823 > | Sterile |
*
UCLA and UCSF use different mobile phases.