Review and Suggestions on Quality Inspection of Fludeoxyglucose ［18F］ Injection Prepared by Medical Institutions

Abstract

The quality of Fludeoxyglucose ［18F］ injection prepared by medical institutions from 2016 to 2021 was reviewed, in order to provide reference for improving the quality control level and operation standard of Fludeoxyglucose ［18F］ injection prepared by medical institutions. According to the results analyzed by the Chinese Pharmacopoeia from 123 batches of Fludeoxyglucose ［18F］ injection prepared by 38 medical institutions, the unqualified rate of the products was 14.6%, and the unqualified items were mainly due to pH value and residual solvents. By analyzing the causes, preparation and quality control process of the samples, it is considered that the main reason is the lack of quality control awareness of the production unit, and also there are problems such as incomplete quality control inspection items and nonstandard inspection operations of the production unit. It is suggested that medical institutions should strengthen the capability building of preparation and quality control process.

Keywords

• medical institution
• radiopharmaceuticals
• fludeoxyglucose ［18f］ injection
• record inspection