Radiosynthesis and validation of [5-cyano-N-(4-(4-[C-11]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl) furan-2-carboxamide] ([C-11]CPPC), a PET radiotracer for imaging CSF1R, a microglia-specific marker

摘要

In this practitioner protocol, the radiochemical synthesis of [C-11]CPPC is described in detail, and a quality control summary of three validation productions is presented. The results indicate that the radiotracer product can be produced in good radiochemical yield (> 60 mCi (2.22 GBq) at end-of-synthesis (EOS)), at high specific activity (molar activity > 11,435 mCi/mu mole (423 GBq/mu mole) at EOS) and high chemical and radiochemical purity. The entire production conforms to current Good Manufacturing Practice (cGMP) requirements. The final product is formulated as a sterile, pyrogen-free solution suitable for human injection.