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《Chinese New Drugs Journal》 2005-02
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Determination of residual solvents in ioversol by head space-gas chromatography

ZOU Pei~1, LUO Shi-neng~1, WANG Lin-xiang~2, LIU Ya-ling~1, XIE Min-hao~1, HE Yong-jun~1(1 Jiangsu Institute of Nuclear Medicine, Wuxi 214063, China; 2 Centre of Analysis, Southern Yangtze University, Wuxi 214036, China)  
Objective: To establish a method for quantification of residual methanol, n-butanol and 2-methoxyethanol in drug substance ioversol. Methods: Samples dissolved in N, N-dimethylacetamide were loaded onto the head space-GC and then was equilibrated at 80℃ for 45min. Toluene was used as internal standard. The optimal gas chromatography was run in a PEG20M capillary column (30m×0.53mm). The initial column temperature was kept at 50℃ for 2min. The column temperature was then escalated to 200℃ at the rate of 5℃·min~(-1) and subsequently sustained for 10min. The temperature at the injection port and the FID detector were 220℃ and 250℃, respectively. N_2 was used as carrier gas at a flow rate of 1mL·min~(-1). Results: Methanol, n-butanol and 2-methoxyethanol showed a linear plot within 61.5~418.9μg·mL~(-1), 59.3~419.5μg·mL~(-1) and 20~140μg·mL~(-1), respectively, with a mean recovery of 97.7%, 99.5% and 98.6%, respectively. Conclusion: The sensitive and accurate method was reliable in the quantification of residual solvents.
【CateGory Index】: R927
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【Citations】
Chinese Journal Full-text Database 2 Hits
1 LUO Shi-neng,ZOU Pei,LIU Ya-ling,XIE Min-hao,HE Yong-jun, YANG Zheng (Jiangsu Institute of Nuclear Medicine , Wuxi 214063, China );Synthesis of ioversol,a non-ionic x-ray contrast agent[J];Chinese New Drugs Journal;2004-04
2 ZOU Pei1,2,LUO Shi-neng1,LIU Ya-ling1,XIE Min-hao1,HE Yong-jun1,SHEN Yong-jia2(1 Jiangsu Institute of Nuclear Medicine,WuXi 214063,China;2 Institute of Fine Chemicals,East China University of Science and Technology,Shanghai 200237,China);HPLC determination of ioversol[J];Chinese Journal of New Drugs;2004-S1
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