Data summary of the QC for [68Ga]Ga-FAPI-04
| QC test | Method | Acceptance criteria | Results | Guideline |
|---|---|---|---|---|
| Appearance | Visual inspection | Clear, colorless | Pass | KP, EP |
| pH | pH meter | 4.0∼8.0 | 5.5∼5.7 | EP |
| Radionuclidic identity | Half-life | Ga-68: 62∼74 min | 67 min | EP |
| Gamma spectroscopy | 511, 1,077 KeV | 511 KeV | ||
| Radiochemical purity | Radio-ITLC | >95% | >99% | EP |
| Radionuclidic purity | Gamma spectroscopy | 511 keV>99.9% | >99.9% | KP, EP |
| Chemical purity | Spot test | HEPES<20 μg/mL | Pass | EP |
| Membrane filter integrity | Bubble point test | SuporⓇ AEF (Pall Medical)≥46 psi | Pass | EP |
| Foreign insoluble matter | Visual inspection | No particles | Pass | KP, EP |
| Bacterial endotoxin | Limulus amebocyte lysate test | 17.5 EU/Vmax | <5.0 EU/mL | KP, EP |
| Sterility | Tryptic soy broth at 20℃∼25℃ | No growth observed after 14 days | Sterile | KP, EP |
| Fluid thioglycolate medium at 30℃∼35℃ |
Abbreviations: QC, quality control; KP, Korean Pharmacopoeia: EP, European Pharmacopoeia; ITLC, instant thin-layer chromatography; HEPES, 4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid; EU, entotoxin units; Vmax, maximum recommended volume in millilitres.
