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

Table. 1.

Table. 1.

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.

Korean J Clin Lab Sci 2021;53:1-10 https://doi.org/10.15324/kjcls.2021.53.1.1
© 2021 Korean J Clin Lab Sci