Comparison of quality control standards of PET radiopharmaceuticals for tumor in Pharmacopoeia of Europe, the United States and People’s Republic of China

doi:10.5246/jcps.2021.03.020

Abstract

Abstract:

To improve the relevant methods of the quality control standards of tumor Positron Emission Computed Tomography (PET) radiopharmaceuticals and to reduce the clinical application risks of such drugs, this article compares and analyzes the similarities and differences of the quality control standards of tumor PET radiopharmaceuticals in the Pharmacopoeia of People’s Republic of China (ChP2020), European Pharmacopoeia (EP8.0) and United States Pharmacopoeia (USP39), focusing on comparing and analyzing the identification (identification method), inspection (pH, residual solvent, bacterial endotoxin, sterility, and impurities), and content determination (radionuclear purity, radiochemical purity, and radioactive concentration) of tumor PET radiopharmaceuticals. The quality control standards of ChP2020 for tumor PET radiopharmaceuticals are relatively equivalent to the quality control standards of USP39 but are not as stringent as those of EP8.0. In general, EP8.0 has the most comprehensive and strict quality control standards for tumor PET radiopharmaceuticals. The quality control standards of tumor PET radiopharmaceuticals in the Chinese Pharmacopoeia can be improved by referring to international standards, especially the European Pharmacopoeia.

Key words: PET radiopharmaceuticals, Quality control, Pharmacopoeia

Supporting:

Yizi Zhu, Huajun Li, Yubo Zhang, Chaoran Zhao, Shuai Lu, Mingxuan Fan, Mei Han. Comparison of quality control standards of PET radiopharmaceuticals for tumor in Pharmacopoeia of Europe, the United States and People’s Republic of China[J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(3): 246-252.

Figures/Tables 4

References 21

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