Abstract
4123
Introduction: The radiopharmaceutical fluorodeoxyglucose (18F-FDG) is the most extensively utilised. It is mainly used in the diagnosis and staging of various cancers. Because of its wide range of applications, the utilisation of 18F-FDG has increased. For the synthesis of 18F-FDG and other radiopharmaceuticals, multiple types of make and models of automatic synthesis units are available on the market. We manufacture 18F-FDG on a large scale and sell it to consumers. For the standard manufacture of 18F-FDG, we installed three distinct types of autonomous synthesis modules in our facility: IBA – Synthera, Trasis – All-in-One, and Ora – Neptis. In this research, we attempted to compare various parameters of 18F-FDG synthesis modules in terms of yield and labelling efficiency using QC of 18F-FDG produced by all three synthesis modules as the 18F-FDG activity increased.
Methods: We used disposable Cassette/IFP, Reagents and Precursor Mannose Triflate supplied by ABX, Germany. Huayi Isotopes, China supplied H218O with >97% enrichment. Collected data for five productions of 18F-FDG for each synthesis module randomly and compared for yield, synthesis time and quality control parameters like pH, radiochemical purity, residual solvents, kryptofix, endotoxins etc.
Results: We found that 18F-FDG Synthesis time was 21 to 24 minutes in all three. With a range of 12 Ci to 19 Ci of 18F-, the produced 18F-FDG yield was in the range of 60 to 66 %. Radiochemical purity obtained in all three was >95%. Residual solvents (Acetonitrile and Ethanol) were comparatively less in the final product (18F-FDG) produced by IBA – Synthera, but in the other two also within limits specified as per United State Pharmacopeia.
Conclusions: All three synthesis modules also produced 18F-FDG with high purity at higher input activity. The quality of 18F-FDG produced in all three synthesis modules follows specifications provided by United States Pharmacopeia. Synthesis time and yield are more or less similar in all three.