Quality control specification | Acceptance criteria | Average result |
---|---|---|
Activity at End of Synthesis | 1.11–76.96 GBq @ EOS 30 to 2080 mCi @EOS | 10.18 ± 0.22 GBq 572 ± 60 mCi |
Product Volume | 8 mL ± 20% | 7.61 ± 0.2 mL |
pH Determination | 4.5–7.5 | 5 |
Visual Inspection | Clear, colorless solution. Absent of foreign matter. Product vial is intact. | Pass |
Radionuclidic Identity | Principal photopeaks are found at 0.511 MeV, 1.02 MeV and Compton scatter | Pass |
Half-life Determination (minutes) | The measured half-life is between 9.5–10.5 min | 9.99 ± 0.1 min |
Radiochemical Identity | Rf of resazurin = 0.43–0.63 | 0.5 ± 0.05 |
Radiochemical Purity | NLT 95.0% Ammonia N 13 via TLC | 98.61 ± 0.4% |
Residual Solvent Assay | Ethanol NMT 3.1 mg/mL | <LLOD to 0.5 mg/mL |
Sterile Filter Integrity | ≥ manufacturer specification of 46 psi | > 46 psi |
Bacterial Endotoxin Testing (EU/mL) | NMT 10.9 EU/mL | < 5 EU/mL |
Sterility | Sterile | Sterile |
Long Lived Radionuclidic Purity | < 0.5% at time of expiry | < 0.001% (less than lower limit of detection) |