Table 1.

Tests items, acceptance criteria and test methods for [¹⁸F]AlF-P-FAPI.

Test item	Acceptance criteria	Test method
Appearance	Colorless and particle-free	Visual inspection
pH	5.0–8.0	pH strip
Radiochemical purity		Radio-HPLC
[18F]AlF-P-FAPI	≥90%
Sum [18F]F- and [18F]AlF	≤5%
Chemical purity		HPLC with UV detector
Amount of AlF-NOTA-P-FAPI, NOTA-P-FAPI, and metal complexes of NOTA-P-FAPI	≤30 μg per injected volume
Amount of sum of unidentified chemical impurities	≤10 μg per injected volume
Integrity of sterile filter membrane	Bubble point ≥1.5 bar	Bubble point determination
Residual solvent		GC
EtOH	≤10% v/v
DMSO	≤0.1% v/v
Total radioactivity	50–5000 MBq/mL	Dose calibrator
Molar activity	≥3 GBq/μmol	HPLC with UV detector and dose calibrator
Maximum injection volume	≤10 mL	injector
Radionuclide identity—approximate half-life (t1/2)	t1/2 = 110 ± 5 min	Two time point radioactivity measurement in dose calibrator
Radionuclide identity—gamma spectrometry	Gamma energy is 0.511 ± 0.02 MeV, or a total peak 1.022 ± 0.02 MeV	Gamma spectrum on NaI (Tl) spectrometer
Radionuclide purity	≥99.8% of the activity of fluorine-18	Gamma spectrum on NaI (Tl) spectrometer
Sterility	No growth after 14 days of incubation at 37 °C	The Chinese Pharmacopoeia
Bacterial endotoxins	≤17.5 EU per mL	LAL testa

^aLimulus amoebocyte lysate (LAL).