Quality Assurance and Quality Control of Tc-99m Radiopharmaceuticals

Loveless, Vivian; Morgan, Susan H.

doi:10.1007/978-3-030-65245-6_6

Cited by 2 publications

(2 citation statements)

References 6 publications

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“…The radiochemical purity [13] of the complex was determined by the separation of radioactivity into complexed ( 99m Tc-MDPcomplex), free ( 99m TcO 4 -), and reduced hydrolyzed technetium( 99m TcO 2 ) in paper chromatography.…”

Section: Results Discussionmentioning

confidence: 99%

“…The solution was shaken and kept in rest for 20 minutes at room temperature for obtaining 99m Tc-MDP radiopharmaceutical. The radiochemical purity of 99m Tc-MDP was determined using paper chromatography systems [12,13]. Whatman 3mm chromatography paper was used as a stationary phase and acetone and 0.9% sodium chloride solution were used as mobile phase to separate reduced 99m Tc ( 99m TcO 2 ) and 99m Tc-MDP from pertechnetate on ( 99m TcO 4 − ).…”

Section: Radio-labeling and Radiochemical Purity Determinationmentioning

confidence: 99%

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

Tasnim,

Akhter,

Rahman

et al. 2023

Preprint

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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.

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Section: Results Discussionmentioning

confidence: 99%

Section: Radio-labeling and Radiochemical Purity Determinationmentioning

confidence: 99%