Radiopharmaceutical stability studies of FDG and NaF when dispensed in a unit dose syringe: Application to commercial distribution and in-house PET Imaging Center studies during normal working hours

Article Figures & Data

	[¹⁸F]FDG Stability Testing of Syringes performed 12hrs EOS	[¹⁸F]NaF Stability Testing of Syringes performed 12hrs EOS
Test	Specification	Specification
Appearance	clear colorless solution free of visible particulate matter	Same as FDG
pH	4.5 - 7.5	Same as FDG
Radionuclidic identity	TÂ½ between105min and 115min	Same as FDG
Radiochemical purity	&gt 90%	>95%
Radiochemical identity	[¹⁸F]FDG R_f = ±10% R_f of [¹⁹F]FDG standard	Radiochemical purity and radionuclidic identity tests meet specification
Radioactive concentration	+10% of initial radioactive concentration when decay corrected back to EOS	Same as FDG
Stabilizer concentration: ethanol	0.1% to 0.5% w/w
Bacterial endotoxin	PTS: &lt 21.875 EU/mL	Same as FDG
Sterility	No growth after 14 days	Same as FDG
Radionuclidic purity	&gt 99.5%	Same as FDG
Chlorodeoxyglucose (Cl-DG)	NMT 125Âµg/mL