Table 4.
Specifications of [68Ga]Ga-DOTA-TOC and [68Ga]Ga-PSMA-11
| Test | Specifications [68Ga]Ga-DOTA-TOC | Specifications [68Ga]Ga-PSMA-11 (In Ph. Eur. 10.4, 3044) | Method |
|---|---|---|---|
| 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 |