BioMed Research International / 2014 / Article / Tab 1

Research Article

Design of CGMP Production of 18F- and 68Ga-Radiopharmaceuticals

Table 1

USP and EP criteria for release of PET drug product.

PET drugs

pH valueEndotoxin test
Radiochemistry puritySterility test
Radiochemistry identityStability test
Radionuclide purityResidual solvents test
Radionuclide identityKryptofix 222 test (for FDG)
Concentration of activity