Synthesis, quality control and dosimetry of the radiopharmaceutical 18F-sodium fluoride produced at the Center for Development of Nuclear Technology - CDTN
DOI:
https://doi.org/10.1590/S1984-82502010000300021Keywords:
Radiopharmaceuticals^i1^sbiodistribut, Sodium fluoride 18F^i1^sproduct, Sodium fluoride 18F^i1^squality cont, Sodium fluoride. 18F^i1^sdosime, Bone imagingAbstract
18F-Sodium fluoride (Na18F) is a radiopharmaceutical used for diagnosis in nuclear medicine by positron emission tomography (PET) imaging. Bone scintigraphy is normally performed using 99mTc-MDP. However, 18F PET scans promise high quality imaging with increased resolution and improved sensitivity and specificity. In order to make available a tool for more specific studies of tumors and non-oncological diseases of bone tissue, the UPPR/CDTN team undertook the production and quality control of Na18F injectable solution with the physical-chemical, microbiological and biological characteristics recommended in the U.S. Pharmacopeia. Na18F radiochemical purity was 96.7 ± 1.3 %, with Rf= 0.026 ± 0.006. The product presented a pH of 5.3 ± 0.6, half life of 109.0 ± 0.8 minutes, endotoxin limit < 5.0 EU.mL-1 and no microbial contaminants. The biodistribution of Na18F was similar to that described in the literature, with a clearance of 0.19 mL.min-1 and distribution volume of 18.76 mL. The highest bone concentration (5.0 ± 0.5 %ID.g-1) was observed 20 minutes after injection. Na18F produced at the UPPR presented all the quality assurance requirements of the U.S. Pharmacopeia and can be safely used for clinical bone imaging.Downloads
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Published
2010-09-01
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Synthesis, quality control and dosimetry of the radiopharmaceutical 18F-sodium fluoride produced at the Center for Development of Nuclear Technology - CDTN . (2010). Brazilian Journal of Pharmaceutical Sciences, 46(3), 563-569. https://doi.org/10.1590/S1984-82502010000300021