中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 43-46.
DOI: 10.19803/j.1672-8629.20240582

• 放射性药品监管科学研究专栏 • 上一篇    下一篇

氟[18F]脱氧葡糖注射液质控关键杂质氨基聚醚对照品的定值研究

孙得洋, 孙葭北, 李文龙, 贾娟娟, 张文在, 刘燕, 黄海伟*, 姚静#   

  1. 国家药品监督管理局化学药品质量研究与评价重点实验室,中国食品药品检定研究院化学药品检定所,北京 102629
  • 收稿日期:2024-08-15 出版日期:2025-01-15 发布日期:2025-01-22
  • 通讯作者: *黄海伟,男,副研究员,本科,药物质量控制。E-mail: huanghw@nifdc.org.cn # 为共同通信作者。
  • 作者简介:孙得洋,男,助理研究员,博士,药物质量控制。
  • 基金资助:
    国家科技重大专项重大新药创制（2017ZX09101001）

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

SUN Deyang, SUN Jiabei, LI Wenlong, JIA Juanjuan, ZHANG Wenzai, LIU Yan, HUANG Haiwei*, YAO Jing#   

  1. NMPA Key Lab for Quality Research and Chemical Drug, National Institutes for Food and Drug Control Institute for Chemical Drug Control, Beijing 102629, China
  • Received:2024-08-15 Online:2025-01-15 Published:2025-01-22

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摘要： 目的 分析质量平衡法和定量核磁共振法对氟[18F]脱氧葡糖注射液质控关键杂质氨基聚醚开展对照品定值研究。方法 分别采用紫外检测器和电喷雾检测器作为高效液相色谱法的检测器对氨基聚醚待测样品进行纯度检查;同时测定样品中水分、残留溶剂及炽灼残渣。以质量平衡法对氨基聚醚进行定值研究;并以定量核磁共振法进一步对该样品进行佐证定值研究。结果 紫外检测器和电喷雾检测器测定氨基聚醚纯度均为100%;质量平衡法的定值结果为99.75%,定量核磁共振法的定值结果为99.78%。结论 质量平衡法与定量核磁共振法对氨基聚醚定值结果一致,氨基聚醚对照品可用于氟[18F]脱氧葡糖注射液及F-18取代放射性药物的质量控制。

关键词: 放射性药品, 氨基聚醚, 对照品, 有关物质, 电喷雾检测器, 定量核磁共振法, 质量平衡法, 质量控制

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

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