Table 5 Quality control results at product release 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 | Complies/Does not comply |
|---|---|---|---|---|
At product release | ||||
Appearance | Clear, colourless | Clear, colourless | Clear, colourless | Complies |
Radionuclidic identity of fluorine-18 [keV] | 511 ±10 | 511 ±10 | 511 ±10 | Complies |
Radionuclidic identity of fluorine-18 [h] | 1.82 | 1.82 | 1.81 | Complies |
Radionuclidic purity of fluorine-18 [%] | ≥99 | ≥99 | ≥99 | Complies |
Radiochemical identity of [18F]DPA-714 [min] | 0.36 | 0.32 | 0.03 | Complies |
Radiochemical purity of [18F]DPA-714 [%] | 100 | 100 | 100 | Complies |
pH | 6.8 | 6.6 | 6.8 | Complies |
Chemical concentration of DPA-714 [mg/mL] | ≤0.01 | ≤0.01 | ≤0.01 | Complies |
Chemical concentration of any impurity above disregard limit [mg/mL] | ≤0.01 | ≤0.01 | ≤0.01 | Complies |
Sum of DPA-714 and all impurities above disregard limit [mg/mL] | ≤0.05 | ≤0.05 | ≤0.05 | Complies |
Molar activity [GBq/µmol] | 173 | 211 | 117 | Complies |
Chemical concentration TEA [mg/mL] | <0.26 | <0.26 | <0.26 | Complies |
Bacterial endotoxins [IU/mL] | <0.5 | <0.5 | <0.5 | Complies |
Sterile filter integrity [bar] | 3.48 | 3.38 | 3.38 | Complies |
After product release | ||||
Radionuclidic impurities with a half-life longer than 2 h | None | None | None | Complies |
Acetonitrile [mg/mL] | 0.02 | 0.03 | 0.02 | Complies |
Ethanol [mg/mL] | 34 | 42 | 40 | Complies |
Sterility | Sterile | Sterile | Sterile | Complies |
Bioburden [CFU]a | <1 | <1 | <1 | Complies |