^(18)F-FDG和^(13)N-NH_3的质量控制研究

Quality control of ^(18) F-FDG and ^(13) N-NH_3·H_2O for positron emission tomography

目的 研究18F 脱氧葡萄糖 (FDG)和13 N NH3 ·H2 O的质量控制并建立其规范。方法 采用PETtrace回旋加速器 18FDG及13 NH3 合成系统 ,制备18F FDG和13 N NH3 ·H2 O注射液 ,研究其质量控制内容与方法 ,测定其质量控制指标。结果 建立了可行的生产18F FDG和13 N NH3 ·H2 O工艺流程和规范 ,其校正的最终产品放化产率分别约为 35 %和 5 4% ,化学纯度均大于 98% ,放射化学纯度均大于 95 % ,无菌无热原实验阴性 ,其他各项质量控制指标均达到药典要求。结论 应对常规生产过程实行控制 。

Objective To study the quality control of 2 deoxy 2 18 F fluoro D glucose ( 18 F FDG) and 13 N NH 3·H 2O as short lived radiopharmaceuticals for positron emission tomography (PET), and to establish and recommend general procedures for the quality control. Methods 18 F FDG and 13 N NH 3·H 2O were synthesized by PET trace cyclotron 18 F FDG synthetic system and 13 N NH 3 synthetic system, respectively. Contents and analytical methods of quality control for 18 F FDG and 13 N NH 3·H 2O were investigated, and the quality criteria was achieved by strict control of the determining parameters with standard procedures. Results The adequate production procedures of 18 F FDG and 13 N NH 3·H 2O were established. The corrected radiochemical yields of the produced 18 F FDG and 13 N NH 3·H 2O were about 35% and 54%, both radiochemical purities were more than 95%, and the chemical purities were both above 98% tested by HPLC and TLC, respectively. Tests on sterility and apyrogenicity of 18 F FDG and 13 N NH 3·H 2O with standard procedures were negative, and tests on other quality criteria were also carried out by standard procedures. All quality parameters met the requirements of the local pharmacopoeia. Conclusion In routine production for clinical use, in process control and tests on the main quality criteria ensure the development and production of safe and efficacious short lived radiopharmaceuticals for clinical PET imaging.