Table 3 Results of synthesis and quality control tests for [¹⁸F]PSMA-1007 injection solution

Activity yields (MBq)

-

7,580

8,570

7,690

Appearance

Clear and colorless

Clear and colorless

Clear and colorless

Clear and colorless

Particle

None

None

None

None

Identity of

[¹⁸F]PSMA-1007 (min)

RT of PSMA-1007

+ 0.3–+ 0.7

+ 0.4

+ 0.4

+ 0.4

Half-life (min)

105–115

110

110

109

Concentration of activity yields (MBq/mL)

> 18.5

610.7

667.5

621.5

Ethanol (v/v %)

< 10.0

7.8

7.9

7.9

Residual MeCN (ppm)

< 410

< 10

< 10

< 10

Residual DMSO (ppm)

< 5,000

< 138

< 138

< 138

PSMA-1007 (μg/mL)

< 10

0.5

0.8

0.7

(Molar activity (GBq/μmol))

-

1,204

829

907

Highest single chemical impurity (μg/mL)

< 10

0.7

0.9

1.0

Total chemical impurities + PSMA-1007 (μg/mL)

< 50

2.7

3.1

3.2

TBA (μg/mL)

< 260

< 26

< 26

< 26

Radionuclidic identity

Exhibits the peak at 511 keV

Exhibits the peak at 511 keV

Exhibits the peak at 511 keV

Exhibits the peak at 511 keV

Radiochemical purity (at EOS) (%)

> 95

98

97

98

[¹⁸F]Fluoride (at EOS) (%)

< 5

< 5

< 5

< 5

Radiochemical purity

(6 h after EOS)

> 95

97

97

98

[¹⁸F]Fluoride (6 h after EOS)

< 5

< 5

< 5

< 5

Radionuclidic purity

Exhibits no peak except 511 keV and 1022 keV

Exhibits no peak except 511 keV and 1022 keV

Exhibits no peak except 511 keV and 1022 keV

Exhibits no peak except 511 keV and 1022 keV

pH

4.5–8.5

6.6

6.7

6.7

Sterility

Sterile

Sterile

Sterile

Sterile

Endotoxin (EU/mL)

< 15.0

< 2.0

< 2.0

< 2.0

Filter integrity test (kPa)

> 286

318

317

327