Quality control tests and release criteria of radiopharmaceuticals
| Test | Method | Acceptance criteria |
|---|---|---|
| Sterility | Tryptic soy broth at 20∼25°C | No growth observed after 14 days |
| Fluid thioglycolate medium at 30∼35°C | ||
| Bacterial endotoxin | Limulus amebocyte lysate test | 175 EU/Vmax |
| Membrane filter integrity | Bubble point test | Manufacturer’s recommendations |
| Appearance | Visual inspection | Clear and colorless |
| Identity | TLC | Rf of reference standard |
| Radionuclidic identity | Half-life | F-18: 105∼115 min |
| Gamma spectroscopy | 511 keV ≥99.9% | |
| Radiochemical purity | TLC or HPLC | KP, USP, EP |
| Radionuclidic purity | Gamma spectroscopy | Photon energy of 511 keV or 1022 KeV |
| Chemical purity | TLC | KryptofixⓇ 222 <50 μg/mL |
| Tetrabutylammonium ≤2.6 mg/Vmax | ||
| Residual solvents | GC | Acetonitrile: ≤4.1 mg/Vmax |
| Acetone: ≤50 mg/Vmax | ||
| DMSO: ≤50 mg/Vmax | ||
| EtOH: ≤10% v/v | ||
| pH | pH meter | KP, USP, EP |
| Foreign insoluble matter | Visual inspection | KP, USP, EP |
| Strength | Dose calibrator, balance | KP, USP, EP |
| Molar activity | HPLC | KP, USP, EP |
Abbreviations: EU, entotoxin units; Vmax, maximum recommended volume in millilitres; TLC, thin-layer chromatography; Rf, retention factor; HPLC, high performance liquid chromatography; KP, Korean Pharmacopoeia; USP, United States Pharmacopeia; EP, European Pharmacopoeia; GC, Gas chromatography.
