Table 2 Summary of QC tests of [⁶⁸Ga]Ga-FAPI-46 and [⁶⁸Ga]Ga-DOTA-TOC

Appearance

Clear or slightly yellow and free of particles

Conform

Conform

pH

4.0–8.0

5.83 ± 0.1

5.83 ± 0.1

Total radiochemical purity^a (%)

 ≥ 91

96.0 ± 0.40

97.6 ± 1.20

Filter integrity (bar)

 ≥ 3.5

4.1 ± 0.1

4.2 ± 0.1

Radionuclide identity by half-life (min)

62–74

67.5 ± 0.3

68 ± 0.3

Bacterial endotoxins (EU/mL)

 < 17.5

 < 5.0

 < 5.0

Ethanol (%) G.C

 < 10

6.7 ± 0.2

6.1 ± 0.3

Radiochemical stability after 3 h (%)

 ≥ 91

95.8 ± 0.80

97.8 ± 0.60