Qualitative assessment of dextrose five percent intravenous infusion used in Lusaka

Abstract

Good quality of Technetium 99m eluate (99mTc) as a radionuclide used in diagnostic imaging procedures is important for proper diagnosis, to avoid patients’ unnecessary exposure to radiation and to reduce the number of repeat nuclear imaging. However, presence of impurities in 99mTc eluate, may produce radiolytic effects, bio-distribution and/or inadequate localization in organs of interest, resulting in poor images. The impurities may interfere with diagnostic interpretation of the images by masking and mimicking disease. The main objective of this study was to determine the quality of 99mTc eluate, while specifically we determined the radionuclidic and radiochemical, chemical impurity, pH and physical characteristics of 99mTc eluate. A cross sectional study, was conducted at the University Teaching Hospitals (UTHs – Adult Hospital) and National Institute of scientific and industrial research (NISIR) in Lusaka from September 2016 to March 2017. Six 99Mo/99Tc generators that were available during the study period were sampled from each generator collected at two time points (96 hours and 120 hours from the time manufacture date). The radionuclidic purity, radiochemical purity, chemical purity, pH and physical characteristics of the of the 99mTc eluate obtained from the Molybedenum-99/Technetium- 99 (99Mo/99Tc) generators were determined and results were compared with the British Pharmacopeia standards and those set by the manufacturers. GraphPad Prism version 5 was used to analyse the data with the p value of < 0.05 considered statistically significant. The median for radionuclidic purity at 96 hours was 0.003 (0.002 – 0.005) and at 120 hours was 0.003 (0.00 – 0.015) p value=0.39. The median pH at 96 hours was 5.94 (5.79 – 6.05) and at 120 hours was 5.96 (5.82 – 6.09); p = 0.06. For radiochemical test at 96 hours it was 98.3 (97.5 – 98.9) percent and at 120 hours was 98.8 (98.4 – 99.3) percent p = 0.06. All the parameters that were analysed were within the acceptable ranges and hence met the British Pharmacopeia standards