Abstract
An automated production of pharmaceutical grade 3′-deoxy-3′-[18F]fluorothymidine ([18F]FLT) with solid phase extraction (SPE) purification using 5′-O-(Benzoyl)-2,3′anhydrothymidine precursor (Benzoyl-Anhydro) poses a major challenge. Herein, an automated, one-pot, two-step, radiochemical synthesis of [18F]FLT using benzoyl-anhydro precursor and subsequent optimization of SPE purification (using readily available SepPak® cartridges) while maintaining radiochemical purity, chemical purity and residual solvent levels within the specified limits has been reported. The current method yields pharmaceutical grade [18F]FLT suitable for inclusion as a generic product in different pharmacopeia. The desired clinical results add support to indigenously produced Sep-Pak® purified [18F]FLT as a pharmaceutical grade diagnostic radiopharmaceutical.
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The authors thank the staff of the Scintigraphy Section, Clinical Nuclear Medicine and the Animal house of RMC, BARC for providing facilities for carrying out the work. The support and encouragement of Director, Medical Group, Bhabha Atomic Research Centre is being gratefully acknowledged.
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Mitra, A., Chakraborty, A., Upadhye, T. et al. Clinical efficacy of Sep-Pak® assisted one pot automated synthesis of pharmaceutical grade [18F]FLT using 5′-O-(benzoyl)-2,3′-anhydrothymidine precursor. J Radioanal Nucl Chem 327, 585–596 (2021). https://doi.org/10.1007/s10967-020-07531-9
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DOI: https://doi.org/10.1007/s10967-020-07531-9