Table 2 Summary of the product specifications for 50 μg PentixaFor, n ≥ 3
From: Fully-automated production of [68Ga]Ga-PentixaFor on the module Modular Lab-PharmTracer
Test | Acceptance criteria | [68Ga]Ga-PentixaFor |
|---|---|---|
Radiochemical purity (radio-HPLC) | > 95% | 99.8% |
Radiochemical purity (radio-iTLC) | > 95% | 99.7% |
pH | 4–8.5 | 5 |
Radioactivity concentration | > 50 MBq/ mL | 120–190 MBq/ mL |
Radioactivity | > 150 MBq | 1080–1700 MBq (depending on amount of generators used) |
Volume | 2–10 mL | 9 mL |
Color | Colorless | Colorless |
Molar radioactivity | 1-60 MBq/ nmol | 27-42.5 MBq/nmol |
Radionuclidic purity | > 99.9% | 99.9 % |
68Ge breakthrough | < 0.001% | 0.0002% |
Endotoxins | < 19.0 IE/mL | < 0.5 IE/mL |
Stability over 4 h | > 90% | 99.9% |
EtOH content | < 10% | ≤ 6.2% (calculated) |