Table 4 Specifications of [⁶⁸Ga]Ga-DOTA-TOC and [⁶⁸Ga]Ga-PSMA-11

Appearance

Clear, colourless solution

Clear, colourless solution

Visual

pH

4–8

4–8

pH strips

Endotoxins

 < 175I.E./V (maximal dose in mL)

 < 175I.E./V (maximal dose in mL)

Radiochemical identity and Purity

 > 91% overall purity

Colloidal ⁶⁸Ga: < 3%

 > 95% overall purity

Colloidal ⁶⁸Ga: < 3%

TLC

Free ⁶⁸GaCl₃: < 2%

 > 95% overall purity

HPLC

Radionuclidic identity

0.511 MeV, 1.077 MeV, sum peak 1.022 MeV

0.511 MeV, 1.077 MeV, sum peak 1.022 MeV

Gamma spectrometry

62 – 74 min

61 – 75 min

Half-life

Radio nuclidic purity

⁶⁸Ge < 0.001%

⁶⁸Ge < 0.001%

Gamma spectrometry

Residual solvents

Ethanol max. 10% (V/V) or 2.5 g/dose

Ethanol max. 10% (V/V) or 2.5 g/dose

GC

Chemical Purity

Edotreotide, Galliumedotreotide, others

 < 50 µg/V

PSMA-11, gallium PSMA-11, others < 30 µg/V

HPLC 220 nm detection (DOTA-TOC), 280 nm (PSMA-11)

HEPES < 200 µg/V

HEPES < 500 µg/V

TLC

Sterility

Sterile

Sterile

Membrane filtration