Table 3 Results of GMP syntheses with regard to the specifications of the European Pharmacopeia
Tests | Methods | Specifications | Batch 1 | Batch 2 | Batch 3 |
|---|---|---|---|---|---|
Appearance | Visual | Clear, colorless solution | Complies | Complies | Complies |
Identification: Photons γ emission peak | γ-Spectrometry (Ph. Eur. 2.2.66) | Principal peak at 0.511 MeV and 1.077 MeV, possible sum peak at 1.022 MeV | 506 kEv | 518 kEv | 492 kEv |
Period | Ionization chamber (Ph. Eur. 2.2.66) | 62–74 min | 66.3 min | 69.3 min | 64.4 min |
pH value | pH strips (Ph. Eur. 4.1.1 1178900 and 2.2.4) | 5.0 – 8.0 | 6.5 | 6.5 | 6.5 |
Sterility | Direct inoculation (Ph. Eur. 2.6.1 + 0125) | Sterile | Complies | Complies | Complies |
Bacterial endotoxins | LAL-test (Ph. Eur. 2.6.14) | < 15 EU/mL | < 5 EU/mL | < 5 EU/mL | < 5 EU/mL |
Radionuclidic purity 68Ga 68Ge and γ-emitted impurities | γ-Spectrometry (Ph. Eur. 2.2.66 + 0125) | ≥ 99.9% ≤ 0.001% | Complies | Complies | Complies |
Radiochemical purity [68Ga]Ga-PentixaFor | HPLC (Ph. Eur. 2.2.29) | ≥ 95% | 99.8% | 99.8% | 99.9% |
68Ga3+chloride | ≤ 2% | 0.22% | 0.24% | 0.07% | |
[68Ga]Ga-PentixaFor | ITLC (Ph. Eur. 2.2.27) | ≥ 95% | 98.8% | 99.2% | 99.3% |
68Ga3+chloride and 68Ga in colloidal forms | ≤ 2% | 0.42% | 0.85% | 0.20% | |
≤ 3% | 0.77% | 0.56% | 0.49% | ||
Filter integrity test | Non-destructive test (Ph. Eur. 5.1.1) | Bubble point measurement > 3450 mbar) | Complies | Complies | Complies |
Radioactivity | Ionization chamber (Ph. Eur. 2.2.66) | 200–1400 MBq | 586 MBq | 661 MBq | 594 MBq |
Specific Activity | – | – | 11.7 MBq/µg | 13.2 MBq/µg | 11.9 MBq/µg |