Comprehensive Analysis and Quality Assessment of Freeze Dried Methylene Diphosphonate Labelled with 99m-Technetium: An Extensive Comparison of Biodistribution Study with Commercial Standards

Abstract

Abstract Objective:Technetium-99m (99mTc) is an important radionuclide used for the prognosis of bone scintigraphy labelled with a suitable kit. Methodology: The present investigations focus on the aseptic preparation and application of the methylene di-phosphonic acid (MDP) kit on bio-organ after labeling with 99mTc collected from a 99Mo/99mTc generator. Result:Before going to bio-application of the labelled kit, radiochemical purity was determined by paper chromatography using the High Purity Germanium (HPGe) detector and the radiochemical purity of 99mTc-MDP was found to be 99%. Furthermore, negative results were found for pyrogen and bacterial endotoxin tests; fungal growth was also absent. Radiation dose uptake in different organs of Wister rats was measured by a dose calibrator, and observed results indicate the highest accumulation of 99mTc-MDP in the skull and skeletal part. This study also performed a comparative study model between laboratory and commercially prepared Monrol MDP kits. This study was performed as bio-application of laboratory prepared 99mTc-MDP prior to commercial production of cold kit at radioisotope production division of Bangladesh Atomic Energy Commission. Conclusion: Overall, the observations from this study are within the accepted range and provide prospect for commercial production of the kits for human administration.