Table 1.
Batch analysis table of four consecutive batches of 68Ga-DOTA-MGS5.
| Parameter | Method | Acceptance Criteria | Results (n = 4) |
|---|---|---|---|
| Appearance | Visual inspection | Clear, colorless solution, free of visible particles | conforms |
| pH | Indicator strip | 4.0–8.0 | 6.0 |
| Volume | Graduated vial | 8.5 (range 7–12 mL) | 8.5 mL |
| Radioactivity concentration | MBq/mL | 9–185 MBq/mL | 112 ± 20 MBq/mL |
| Radionuclide identity | Gamma-ray spectrometry | 511 keV; 1022 keV | conforms |
| Radionuclide identity | Half-life | 62–74 min | 68.3 ± 0.3 min |
| Identity of 68Ga-DOTA-MGS5 (comparison with reference) |
HPLC | RRT 0.9–1.1 | conforms |
| Proportion of 68Ga-DOTA-MGS5 | HPLC (T) | not specified | 0.949 ± 0.012 |
| Radiochemical impurities with RRT 0.6–0.9 and 1.1–1.4 |
HPLC | ≤6% | 4.3 ± 0.8% |
| Free or colloidal gallium-68 (retardation factor <0.2) |
iTLC (A) | ≤3% | 0.9 ± 0.5% |
| Radiochemical purity | RCP = (100 – A) × T | ≥91% | 94.1 ± 1.3% |
| DOTA-MGS5, 68Ga-DOTA-MGS5 and related substances (RRT 0.8–1.2) |
HPLC | ≤50 µg/V | <40 µg |
| Ethanol content | Gas chromatography | ≤10 % (v/v) | 6.2 ± 0.5% |
| Radionuclide purity | Gamma-ray spectrometry | Ge-68: ≤0.001% (after ≥48 h) |
conforms |
| Bacterial Endotoxins | LAL test | ≤175 IU/V | <3 IU/V |
| Sterility | Ph. Eur. | sterile | conforms |