Parameter | QC specification | QC result |
Appearance | Clear, colorless | Pass |
Volume | 0.5–1.0 mL | 0.5 mL |
Injection dose | 18.5–37 MBq | 37 MBq |
pH | 4.0–8.0 | 7.0 |
Radio–thin-layer chromatography | >95% | >99% |
Radio–high-performance liquid chromatography | >95% | >99% |
Ethanol | <5% | 0 |
Endotoxins | <15 EU/mL | Pass |
Sterility | Sterile | Pass |
Specific activity | 111 GBq/μmol | Pass |