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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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奥硝唑氯化钠注射液主要杂质的结构鉴定

Characterization of major impurity in ornidazole and sodium chloride injection

分类号:
出版年·卷·期(页码):2012,32 (10):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 对奥硝唑氯化钠注射液的主要杂质进行结构分析。 方法: 采用HPLC-QTOF-MS联用技术对该杂质进行鉴定;利用制备高效液相色谱从奥硝唑氯化钠注射液中分离制备该杂质,并进一步采用核磁技术进行结构确证。 结果: 确证了奥硝唑氯化钠注射液的1个主要杂质的结构。 结论: 本研究对奥硝唑氯化钠注射液的杂质分析、质量控制具有重要作用。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To identify the structure of the major impurity of ornidazole and sodium chloride injection. Methods: HPLC-QTOF-MS was adopted to analyze the structure of this impurity;the impurity was separated from ornidazole and sodium chloride injection by prep-HPLC,and its structure was further identified by NMR. Results: The chemical structure of the major impurity of ornidazole and sodium chloride injection was elucidated. Conclusion: The study offers scientific data for studying the impurities of ornidazole and sodium chloride injection and improving its quality.

-----参考文献:---------------------------------------------------------------------------------------
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10 LI Zhong-hong(李忠红),WANG Xiao-juan(汪晓娟),CAI Mei-ming(蔡美明),et al.Analysis of ornidazole's related substances by LC-ESI-MS(奥硝唑有关物质的液相色谱-电喷雾离子化-质谱联用分析).Drug Stand China(中国药品标准),2008,9(4):277
11 ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录) XIX F

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