Good practices for the automated production of 18F-SiFA radiopharmaceuticals

EJNMMI Radiopharmacy and Chemistry

Table 1 Specifications and QC results for [¹⁸F]SiTATE manufactured at LMU Munich (n = 308)

Test	Specifications	Results	Method
Appearance	Clear, colorless, no particles	Pass	Visual inspection
Radiochemical purity	≥ 95%	97 ± 0.9%	HPLC^a
Chemical purity	≤ 5.7 µg/ml	2.1 ± 1.6 µg/ml	HPLC^a
Identity	0.93–1.07 RRT^b	0.97 ± 0.01	HPLC^a
Residual solvents	≤ 10% (v/v) EtOH ≤ 410 ppm MeCN	5.8 ± 0.7% 29 ± 6 ppm	GC^c
Half life	99–120 min	110 ± 1.32 min	Dose calibrator
Radionuclide identity	511 keV	Pass	Gamma spectrometry
Radionuclide purity	≥ 99.9%	Pass	Gamma spectrometry
pH	5–7	6.2 ± 0.2	pH meter
Kryptofix K₂₂₂	≤ 733 µg/ml	Pass	Colorimetric spot test
Endotoxins	≤ 10 EU/ml	Pass	LAL test^d
Sterility	Sterile	Sterile	Membrane filtration
Filter integrity	≥ 3.3 bar	Pass	Bubble point test