Table 6 Results of radiolabelling of [68Ga]Ga-EMP100 according to Ph. Eur. 51900
From: Fully automated radiolabeling of [68Ga]Ga-EMP100 targeting c-MET for PET-CT clinical imaging
Test | Method | Specifications | Batch 1 | Batch 2 | Batch 3 |
|---|---|---|---|---|---|
Aspect | Visual | Clear, colourless solution | Yes | Yes | Yes |
Radioactivity | Activimeter | > 500 MBq | 1025 MBq | 1065 MBq | 1084 MBq |
Radioactivity concentration | Activimeter | > 50 MBq/mL | 102.5 MBq/mL | 106.5 MBq/mL | 108.4 MBq/mL |
Molar activity | Activimeter | > 10 GBq/µmol | 51 GBq/µmol | 53 GBq/µmol | 54 GBq/µmol |
Chemical identification | Radio-HPLC | Rt [68Ga]Ga-EMP100 = Rt Standard ± 5% | + 0.47% | + 0.62% | + 0.46% |
Radio-TLC 1M AcNH4 Methanol (1:1) | [68Ga]Ga-EMP100: Rf = [0.8;1] | Rf = 0.9 | Rf = 1 | Rf = 0.9 | |
[68Ga]Ga-colloidal: Rf = [0;0.1] | Rf = 0 | Rf = 0 | Rf = 0 | ||
Radiochemical purity | Radio HPLC | RCP [68Ga]Ga-EMP100 > 95.00% | 99.64% | 99.70% | 99.82% |
Free [68Ga]GaCl3 ≤ 5% | 0.36% | 0.30% | 0.18% | ||
Radio TLC 1M AcNH4 Methanol (1:1) | [68Ga]Ga-EMP100 > 95% | 99.44% | 99.75% | 99.99% | |
[68Ga]Ga-colloidal ≤ 5% | 0.56% | 0.25% | 0.01% | ||
RCP (overall) | [68Ga]Ga-EMP100 (overall) > 95.00% | 99.08% | 99.45% | 99.81% | |
pH value | pH-strips | 4.0–8.0 | 6.0 | 6.0 | 6.0 |
Bacterial endotoxins | LAL-test | < 17 EU/mL | < 5 EU/mL | < 5 EU/mL | < 5 EU/mL |
Radionuclidic identity | Half-life [68Ga]Ga = 67.6 min | Measured:61–75 min | 64.92 min | 68.23 min | 68.13 min |
Gamma spectrometry | 0.511 MeV | 0.511 MeV | 0.511 MeV | 0.511 MeV | |
Radionuclidic purity | Gamma spectrometry | [68Ge]Ge < 0.001% | 1.12 × 10–5 | 1.08 × 10–5 | 0.95 × 10–5 |
RCY (n.d.c.) | GAIA report | > 50% | 75% | 72% | 75% |
Filter integrity test (GAIA) | Membrane filtration bubble point test | YES or NO | Yes | Yes | Yes |
Sterility | Inoculation 14 days (Ph Eur 20601) | Sterile | Sterile | Sterile | Sterile |
Residual solvents | GC | Ethanol max 10% (v/v) | 8.14% | 7.74% | 6.85% |