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Clinical doses production of pharmaceutical grade Sodium[F]Fluoride using modified integrated fluidic processor in a SYNTHERA® module. | LitMetric

AI Article Synopsis

  • - A new method for producing sodium [F]fluoride ([F]NaF) has been developed using a SYNTHERA module with an upgraded integrated fluidic processor (IFP), achieving over 98% radiochemical yield in just 5 minutes.
  • - The process meets the standards set by the United States Pharmacopeia (USP), ensuring quality for pharmaceutical applications.
  • - A user-friendly graphical interface allows for both manual and automated control of the synthesis process, aiding operators and supporting its use as a diagnostic radiopharmaceutical.

Article Abstract

A fully automated large-scale production of sodium [F]fluoride ([F]NaF) using SYNTHERA module with a modification in integrated fluidic processor (IFP) is reported. This modified IFP module is used to prepare [F]NaF with more than 98% non-decay corrected radiochemical yield (RCY) within 5 min with specifications in accordance with United State Pharmacopeia (USP) monograph. The graphical user interface (GUI) is designed to perform the synthesis steps either manually or automatically and give information to the operator during the course of production. The desired clinical results add support to indigenously produced [F]NaF as a pharmaceutical grade diagnostic radiopharmaceutical.

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Source
http://dx.doi.org/10.1016/j.apradiso.2021.110035DOI Listing

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