Quality control of <sup>18</sup>F-fluoroestradiol for positron emission tomography

YUAN Huiyu; XU Xiaoping; ZHANG Yongping; WANG Minwei; YANG Zhongyi; HE Simin; ZHANG Jianping; BAO Xiao; ZHANG Yingjian

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Quality control of ¹⁸F-fluoroestradiol for positron emission tomography

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- Quality control of ¹⁸F-fluoroestradiol for positron emission tomography
- Vol. 24, Issue 3, Pages: 190-195(2015)
- 作者机构：
  
  1. 复旦大学生物医学影像研究中心,上海,200032
  2. 上海分子影像探针工程技术研究中心筹,上海,200032
  3. 复旦大学附属肿瘤医院核医学科，复旦大学上海医学院肿瘤学系,上海,200032
  4. 上海市质子重离子医院核医学科,上海,201321
- 作者简介：
- 基金信息：
- DOI：
  CLC：
- Published Online：20 October 2015，
  
  Published：20 October 2015
- 稿件说明：
移动端阅览
袁慧瑜,许晓平,张勇平,等. ¹⁸F-雌二醇的质量控制研究[J]. 肿瘤影像学, 2015, 24(3): 190-195
DOI：

袁慧瑜,许晓平,张勇平,等. ¹⁸F-雌二醇的质量控制研究[J]. 肿瘤影像学, 2015, 24(3): 190-195 DOI：

摘要

目的：

研究

F-雌二醇(

F-FES)的质量分析方法以完善质量控制操作规范。

方法：

采用SIEMENS公司Eclipse ST加速器和Explora GN/LC模块，制备

F-FES，根据《中华人民共和国药典》和具体实践研究质量分析方法。

结果：

按

F-FES合成标准操作规程，其校正后放射化学产率为38%，终产品的各项质量指标符合临床检查要求。

结论：

本研究中

F-FES质量控制方法和结果能保证临床用药安全。

Abstract

Objective:

To study the quality control of

F-fluoroestradiol (18F-FES)

and to establish the standard operation procedure (SOP) and quality criteria.

Methods:

F-FES was synthesized by SIEMENS Eclipse ST cyclotron and Explora GN/LC synthetic system. The contents and methods of quality control for

F-FES were investigated

and the quality parameters were determined with standard procedure.

Results:

The SOP of 18F-FES synthesis was established

the corrected radiochemical yield was about 38%. The quality control methods and quality criteria were established according to Chinese Pharmacopoeia based on practice

and all quality parameters met the requirements.

Conclusion:

The methods and results of quality control of

F-FES could ens

ure the drug safety for clinical PET imaging.

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SHAN Fengling

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Related Institution

Department of Nuclear Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center

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Quality control of 18F-fluoroestradiol for positron emission tomography

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Quality control of ¹⁸F-fluoroestradiol for positron emission tomography