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KMID : 1145520190050010048
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Journal of Radiopharmaceuticals and Molecular Probes
2019 Volume.5 No. 1 p.48 ~ p.53
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Establishment of automated manufacturing system for highpurity [18F]Sodium fluoride: 3-year production experience
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Jung Soon-Jae
Kim Jung-Young
Han Sang-Jin
Seo Young-Beom
Lee Kyo-Chul
Ryu Young-Hoon
Choi Jae-Yong
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Abstract
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A bone metastasis is an important factor for prognosis and treatment of breast or prostate cancer patients. [18F]Sodium fluoride ([18F]NaF) is a PET radiopharmaceutical that can detect bone metastasis. Conventional [18F]NaF production process included radioactive metal impurities because the product was prepared by adding saline after beam irradiation to [18O]H2O. In this study, we apply the method of removing radionuclidic impurities. To meet the criteria prescribed by GMP in quality control, we designed the custom-made [18F]NaF automatic module. The mean radiochemical yield was 82.1 ± 4.4% (n = 32) productions for 3 years) and the total preparation time was 4 min. The final produced [18F]NaF solution meets the USP criteria for quality control. Thus, this fully automated system is validated for clinical use.
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KEYWORD
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[18F]Sodium fluoride, Bone scintigraphy, Positron emission tomography
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