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

Table 1.

Data summary of the QC for [18F]fluorocholine

QC test Method Acceptance criteria Result Guideline
Appearance Visual inspection Clear, colorless solution Pass KP, EP
pH pH meter 4.5∼8.5 6∼7 EP
Radionuclidic identity Half-life F-18: 105∼115 min 110±3 min EP
Gamma spectroscopy 511, 1,022 KeV 511 KeV
Radiochemical purity Radio-TLC >90% >99% EP
Radionuclidic purity Gamma spectroscopy 511 keV>99.9% >99.9% KP, EP
Chemical purity Spot test Kryptofix2.2.2<50 μg/mL Pass EP
Residual solvents Gas chromatography DMAE<100 ppm <1 ppm KP, EP
Acetonitrile<400 ppm <1 ppm
Ethanol<5,000 ppm <150 ppm
Dimethyl sulfoxide<5,000 ppm <1 ppm
Membrane filter integrity Bubble point test Supor AEF (Pall Corp.): 46 psi Pass EP
Foreign insoluble matter Visual inspection No particles Pass KP, EP
Bacterial endotoxin Limulus amebocyte lysate test 17.5 EU/Vmax <17.5 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; F-18, fluorine-18; TLC, thin-layer chromatography; DMAE, N,N-dimethylaminoethanol; EU, entotoxin units; ppm, parts per million; Vmax, maximum recommended volume in millilitres.

Korean J Clin Lab Sci 2023;55:261-8 https://doi.org/10.15324/kjcls.2023.55.4.261
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