1. 7-A Block R III, Johar Town, Lahore, Pakistan www.shaukatkhanum.org.pk SHAUKAT KHANUM MEMORIAL CANCER HOSPITAL & RESEARCH CENTRE References Conclusion INTRODUCTION Radiopharmaceuticals are subjected to quality control analysis before injecting the patients to ensure that our product meets the desired result. One of the tests is radiochemical purity to check whether we are delivering right dose to the patients. Radiochemical Purity of a radiopharmaceutical is amount of radioisotope present in chemical entity. 18 F-FDG is used in PET imaging for assessment of malignancy in patients with known or suspected abnormalities diagnosed by other tests, or in cancer patients with an existing diagnosis. IBA Synthera module uses a precursor molecule, Mannose Triflate for the synthesis of 18 F- FDG. The significance of radiochemical purity in Nuclear medicine is appreciated by the fact that the presence of radiochemical impurities in the radiopharmaceutical will alter the biodistribution and result in false result and background too. This also increases probability of giving an excess radiation dose to the patients. European Pharmacopoeia Guidelines states that radiochemical purity of F18-FDG must be 95%. METHODS F18-FDG was synthesized on IBA Synthera module. There are two IBA Synthera modules that have been installed in PET-Hot Lab of our hospital. All these samples were analysed on Radio-HPLC (Raytest). 25 µL of 18F-FDG was injected through rheodyne valve of HPLC and result were analysed as shown in the figure. Radiochemical purity of each batch is taken from daily FDG batch record file. No. of batches which have radiochemical purity above 95 %, 96%, 97%,98% and 99% WERE analysed. Acceptance criteria is greater than 95%. *Arslan Ahmed 1 Atiq-ur-Rehman 1, Rabia Ashfaq 1, Waqas Rafique 2, Muhammad Khalid Nawaz 1, Humayun Bashir 1. 1. Nuclear Medicine Department, Shaukat Khanum Memorial Cancer Hospital & Research Centre-Lahore. 2. University of Oslo, Norway COMPREHENSIVE ANALYSIS OF RADIOCHEMICAL PURITY DURING 1000 18 F-FDG PRODUCTIONS TABLE 1. RADIOCHEMICAL PURITY (RADIO-HPLC) Serial number Radioche mical purity NUMBER OF BATCHES 199%774 298%842 397%901 496%967 595%982 CONCLUSION This scientific study reflects 98.4% batch productions of FDG done at our Centre were having the radiochemical purity of 95% or more which completely meets the international criteria. RESULTS During all these one thousand 18 F- FDG productions, it was observed that 98.2% from total production batches were successful and 1.8% was failure rate. The radio-HPLC data obtained from this study reflected that 774 production-batches had 99% or more radiochemical purity of F18-FDG, 842 productions showed 98% or more, 901 productions showed 97% or more, 967 productions showed 96% or more whereas, 982 productions showed 95% or more radiochemical purity of F18-FDG. Only 18 batches out of one thousand batches showed below 95 % radiochemical purity were failed. Graph 1: Radio-HPLC Chromatograph OBJECTIVE The aim of this study was to evaluate radiochemical purity of 18 F-FDG synthesis through IBA- Synthera module at Shaukat Khanum Hospital Nuclear Medicine Hot Lab during one thousand productions. Radio-HPLC