碘克沙醇-USP34翻译资料.docVIP

Iodixanol 碘克沙醇 (eye oh dix a nol). C35H44I6N6O15 1550.18 1,3-Benzenedicarboxamide,5,5?-[(2-hydroxy-1,3-propanediyl)bis(acetylimino)]bis[N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-. 5,5?-[(2-Hydroxytrimethylene)bis(acetylimino)]bis[N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide] ? Iodixanol contains not less than 98.6 percent and not more than 101.0 percent of C35H44I6N6O15, calculated on the anhydrous basis. Packaging and storage— Preserve in well-closed, light-resistant containers. Store at 25, excursions permitted between 15 and 30. 本品为1,3-苯二甲酰胺，5,5?-[(2-羟基-1,3-丙二基)双(乙酰亚胺基)]双[N,N?-双(2,3-二羟丙基)-2,4,6-三碘-； 5,5?-[(2-羟基丙烷基)双(乙酰亚胺基)]双[N,N?-双(2,3-二羟丙基)-2,4,6-三碘异酞酰胺] [92339-11-2] 按无水物计算，本品含C35H44I6N6O15应为98.6%～101.0%。 【包装和贮藏】密闭容器保存，避光。温度为25℃，允许在15℃~30℃范围内变化。 USP Reference standards 11— USP Iodixanol RS USP Iohexol Related Compound B RS ???5-Amino-N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. USP Iodixanol Related Compound C RS 5-[Acetyl[3-[[3,5-bis[[(2,3-dihydroxypropyl)amino]carbonyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. USP Iodixanol Related Compound D RS 5-[Acetyl(2-hydroxy-3-methoxypropyl)amino]-N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. USP Iodixanol Related Compound E RS 5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5-[[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N?-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. 【USP 对照品】11 碘克沙醇对照品碘克沙醇相关物质B对照品 5-氨基-N,N?-双(2,3-二羟丙基-2,4,6-三碘-1,3-苯二甲酰胺 碘克沙醇相关物质C对照品 5-[乙酰基[3-[[3,5-双[[(2,3-二羟丙基)氨基]羰基]-2,4,6-三碘苯基]氨基]-2-羟丙基]氨基]N,N?-双(2,3-二羟丙基)-2,4,6-三碘-1,3-苯二甲酰胺 碘克沙醇相关物质D对照品 5-[乙酰基(2-羟基-3-甲氧基丙基)氨基]-N,N?-双(2,3-二羟丙基)-2,4,6-三碘-1,3-苯二甲酰胺 碘克沙醇相关物质E对照品 5-[[3-[[3-[[(2,3-二羟丙基)氨基]羰基]-5-[[氨基] 羰基]-2,4,6-三碘苯基](乙酰亚胺基)]-2-羟丙基]-( 乙酰亚胺基)]-N,N?-双(2,3-二羟丙基)-2,4,6-三碘-1,3-苯二甲酰胺 Identification— A: Infrared Absorption 197K. B: The retention tim