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含药物和亚硫酸氢盐的葡萄糖注射液中5-羟甲基糠醛(5-HMF)及相关物质的定量测定。

Quantitation of 5-hydroxymethylfurfural (5-HMF) and related substances in dextrose injections containing drugs and bisulfite.

作者信息

Hryncewicz C L, Koberda M, Konkowski M S

机构信息

Baxter Healthcare Corporation, Round Lake, IL 60073, USA.

出版信息

J Pharm Biomed Anal. 1996 Feb;14(4):429-34. doi: 10.1016/0731-7085(95)01622-8.

DOI:10.1016/0731-7085(95)01622-8
PMID:8729641
Abstract

The spectrophotometric test for 5-hydroxymethylfurfural and related substances, which is included in multiple compendial monographs for dextrose-containing injections, was modified to eliminate interference of bisulfite anion. Experimental formulations containing heparin or dopamine hydrochloride were used in this study. The modified assay was shown to be accurate, precise and rugged. With an appropriate standard, the method can be used to measure 5-HMF in solutions with an approximate quantitation limit of 0.06 ppm.

摘要

用于5-羟甲基糠醛及相关物质的分光光度法检测包含在多个含葡萄糖注射液的药典专论中,该方法进行了修改以消除亚硫酸氢根阴离子的干扰。本研究使用了含有肝素或盐酸多巴胺的实验制剂。结果表明,修改后的检测方法准确、精密且耐用。采用合适的标准品时,该方法可用于测定溶液中的5-羟甲基糠醛,其近似定量限为0.06 ppm。

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