Table 6 Results of the stability study performed 6 hours post-EOS for three validation batches of [18F]DPA-714. Detailed explanation of acceptance specifications can be found in Table 3
From: Optimised GMP-compliant production of [18F]DPA-714 on the Trasis AllinOne module
Test | Batch 1 | Batch 2 | Batch 3 |
|---|---|---|---|
Vial 0.5 mL Vial 10 mL | Vial 0.5 mL Vial 10 mL | Vial 0.5 mL Vial 10 mL | |
Appearance | Clear, colourless | Clear, colourless | Clear, colourless |
pH | 6.9 6.8 | 6.5 6.9 | 6.4 6.5 |
Radiochemical identity of [18F]DPA-714 [min] | 0.34 0.03 | 0.37 0.35 | 0.03 0.34 |
Radiochemical purity of [18F]DPA-714 [%] | 100 | 99.7 100 | 100 |
Chemical concentration of DPA-714 [mg/mL] | ≤0.01 | ≤0.01 | ≤0.01 |
Chemical concentration of any impurity above disregard limit [mg/mL] | ≤0.01 | ≤0.01 | ≤0.01 |
Sum of DPA-714 and all impurities above disregard limit [mg/mL] | ≤0.05 | ≤0.05 | ≤0.05 |