Quality Control of ~(11)C-Carfentanil

To study the quality control of 11C-Carfentanil injection,physical,chemical and biological identification were used.The chemical and radiochemical purity of 11C-Carfentanil Injection were detected by HPLC and Flower Count system;measured the quantity of product by LC-MS,specific activity was calculated later;The PTS was used to detect endotoxin,and other quality control methods were put up to guarantee the security of its clinical application.The produce appeared colorless and transparent,the radiochemical purity was more than 98%,content of the endotoxin was less than 5 EU/mL.The result showed that 11C-Carfentanil injection had fulfilled pharmaceutical quality control request and could be applied safely to animal experiment and clinical diagnosis.