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Table 2 Results of the validation runs of [68Ga]Ga-NeoB

From: GMP-compliant production of [68Ga]Ga-NeoB for positron emission tomography imaging of patients with gastrointestinal stromal tumor

Run #

batch #

  

Reaction

Quality control

 

Buffer

batch

buffer

[ml]

HCl* [ml]

temp.

time

yield**

[MBq]

pH

radionuclide

purity

68Ga-content

RCP: HPLC / TLC

Sterile

A-1

CT00516004

F03517002

0.50

5.0

95.1 °C

10 min

765

3.5

1.13 h

> 99.999%

96.1%

99.0%

yes

A-2

CT00516004

F03517002

0.50

5.0

94.9 °C

9 min

716

3.5

1.12 h

> 99.999%

96.4%

98.7%

yes

A-3

CT00516004

F03517002

0.50

5.0

95.1 °C

8 min

568***

3.4

1.12 h

> 99.999%

97.0%

99.9%

yes

B-1

CT00516004

F03517002

0.55

5.0

95.0 °C

8 min

746

3.8

1.13 h

> 99.999%

98.5%

99.2%

yes

B-2

CT00516004

F03517002

0.55

5.0

95.0 °C

10 min

756

3.8

1.12 h

> 99.999%

97.0%

98.5%

yes

B-3

CT00516004

F03517002

0.55

5.0

95.2 °C

7 min

722

3.7

1.13 h

> 99.999%

98.7%

99.4%

yes

  1. *: Elution volume minus 0.5 mL dead volume of the tubing
  2. **: measured 2–5 min after cool down
  3. ***: second generator elution of the day (first elution 2.5 h before)