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Analytical procedure for quality control of 18F-Choline radiopharmaceutical
Author(s) -
Thanh Vu,
Ngoc Khoan Ha,
Thanh Rin Bui,
Trung Dung Nguyen,
Tuan Linh Pham,
Thi Hai Yen Nguyen,
Thi Thu Hien Doan
Publication year - 2021
Publication title -
tạp chí khoa học và công nghệ việt nam (b, online) (vietnam journal of science and technology - most)/tạp chí khoa học và công nghệ việt nam (điện tử)/tạp chí khoa học và công nghệ việt nam (b, print) (vietnam journal of science and technology - most)
Language(s) - English
Resource type - Journals
eISSN - 2615-9759
pISSN - 1859-4794
DOI - 10.31276/vjst.63(5).10-16
Subject(s) - chromatography , high performance liquid chromatography , chemistry , acetonitrile , choline , analytical chemistry (journal) , biochemistry
18Fluoromethylcholine (18F-Choline, 18F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the 18F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the 18F-FCH was less than 35 min. Identifications of 18F-FCH, radiochemical purity, and 18F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.

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