A Comparison of Criteria and Methods for Quality Control Tests of F-18 FDOPA between USP and EP
Journal
核子醫學暨分子影像雜誌
Journal Volume
27
Journal Issue
4
Pages
220-228
Date Issued
2014
Author(s)
YA-YAO HUANG
Abstract
6-[F-18]-fluoro-L-3,4-dihydroxy-phenylalanine (F-18 FDOPA) has been widely applied in neuroscience and oncology, such as Parkinson’s disease, neuroendocrine tumor and so on. As a result, the acceptance criteria and test methods of the quality control (QC) tests for F-18 FDOPA via electrophilic production have been listed in the U.S. Pharmacopeia (USP) as well as European Pharmacopeia (EP). In order to assist the radiotracer producer and the user to assure that the quality of F-18 FDOPA injection is fit in with international standard, this article is proposed to compare the difference of the QC criteria and the testing methods between the latest edition of USP and EP. Furthermore, it is hope that this article will stimulate the cooperation among related associations and the competent authorities in Taiwan, and develop a set of harmonized and reasonable QC standards for F-18 FDOPA or other PET radiotracers.
SDGs
Type
journal article