The Korean Journal of Clinical Laboratory Science : eISSN 2288-1662 / pISSN 1738-3544

Table 1.

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.

Korean J Clin Lab Sci 2024;56:43-51
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