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

Table 1

USP and EP criteria for release of PET drug product.

PET drugs
pH value	Endotoxin test
Radiochemistry purity	Sterility test
Radiochemistry identity	Stability test
Radionuclide purity	Residual solvents test
Radionuclide identity	Kryptofix 222 test (for FDG)
Concentration of activity