In this practitioner protocol, the radiochemical synthesis of [11 C]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/μmole (423 GBq/μmole) 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.

中文翻译：

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[5-氰基-N-(4-(4-[11 C]甲基哌嗪-1-基)-2-(哌啶-1-基)苯基)呋喃-2-甲酰胺] ([11 C] CPPC)，一种用于对 CSF1R 成像的 PET 放射性示踪剂，一种小胶质细胞特异性标记物

在此从业者协议中，详细描述了 [11 C] CPPC 的放射化学合成，并提供了三个验证产品的质量控制摘要。结果表明，放射性示踪剂产品可以以良好的放射化学产率（合成结束 (EOS) 时 > 60 mCi (2.22 GBq)）、高比活度（摩尔活度 > 11,435 mCi/μmole (423 GBq/μmole) ) 在 EOS) 和高化学和放射化学纯度。整个生产符合现行的良好生产规范 (cGMP) 要求。最终产品配制成适合人体注射的无菌、无热原溶液。