BARC/PUB/2021/0704

 
 

Clinical efficacy of Sep-Pak® assisted one pot automated synthesis of pharmaceutical grade [18F]FLT using 5''-O-(benzoyl)-2,3''-anhydrothymidine precursor

 
     
 
Author(s)

Mitra, A.; Chakraborty, A.; Upadhye, T.; Verma, P.; Rajesh, C.; Lad, S.; Pawar, Y.; Basu, S.; Banerjee, S.
(RMC)

Source

Journal of Radioanalytical and Nuclear Chemistry, 2021. Vol. 327: pp. 585-596

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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