Assignment of Chemical Reference Substance of Aminopolyether -a Key Impurity in Fludeoxyglucose [18F] Injection

doi:10.19803/j.1672-8629.20240582

Abstract

Abstract: Objective To determine the content of aminopolyether using mass balance and quantitative nuclear magnetic resonance (qNMR) respectively. Methods The chromatographic purity of the aminopolyether reference substance was determined using HPLC-UV & HPLC-CAD methods. Moisture, ignition residues and residual solvents were determined with Karl-Fischer-Coulomb method, residue on ignition method and headspace gas chromatography, respectively. The purity of the aminopolyether reference substance was calculated using the mass balance method. Finally, the absolute purity of the aminopolyether reference substance was determined by qNMR. Results The chromatographic purity of the aminopolyether reference substance was 100% as detected with the HPLC-UV method and with the HPLC-CAD method. The result of the mass balance method was 99.75%, compared with 99.78% by qNMR. Conclusion The assignment results of mass balance and qNMR are consistent, so the two methods can guarantee the accuracy of assignment. The aminopolyether reference substance could be used for quality control of fludeoxyglucose [¹⁸F] injection and other F-18 substituted radiopharmaceuticals.

Key words: Radiopharmaceutical, Aminopolyether, Reference Substance, Related Substances, Corona Charged Aerosol Detector, Quantitative Nuclear Magnetic Resonance, Mass Balance, Quality Control

CLC Number:

R917

SUN Deyang, SUN Jiabei, LI Wenlong, JIA Juanjuan, ZHANG Wenzai, LIU Yan, HUANG Haiwei, YAO Jing. Assignment of Chemical Reference Substance of Aminopolyether -a Key Impurity in Fludeoxyglucose [¹⁸F] Injection[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 43-46.

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Assignment of Chemical Reference Substance of Aminopolyether -a Key Impurity in Fludeoxyglucose [¹⁸F] Injection

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