Analysis of residual solvents in 2-[18F]FDG by GC

被引：22

作者：

Channing, MA ^{[1
]}

Huang, BX ^{[1
]}

Eckelman, WC ^{[1
]}

机构：

[1] NIH, Warren G Magnuson Clin Ctr, PET Dept, Bethesda, MD 20892 USA

来源：

NUCLEAR MEDICINE AND BIOLOGY | 2001年 / 28卷 / 04期

关键词：

residual solvents; 2-[F-18]FDG; gas chromatography;

D O I：

10.1016/S0969-8051(00)00213-4

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

A gas chromatography method has been developed for the measurement of the residual acetone, ethanol and acetonitrile in 2-deoxy-2-[F-18] fluoro-D-glucose (2-[F-18]FDG), in accordance with the pending FDA revision on the drug. The detections limits were 0.1 ppm for all three solvents. Good precision and linearity were obtained over ranges spanning the allowable concentration levels proposed by FDA. The amounts of the three solvents in our routine 2-[F-18]FDG products have been found well below the maximum permissible levels. The method is very amenable to quality control testing for the radiopharmaceutical. (C) 2001 Elsevier Science Inc. All rights reserved.

引用

页码：469 / 471

页数：3

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