中国药业2016,Vol.25Issue(17):29-30,31,3.
盐酸伊达比星有关物质研究的新发现
New Discovery in Idarubicin Hydrochloride-Related Substances
陈爽 1张舒1
作者信息
- 1. 浙江省食品药品检验研究院,浙江 杭州 310014
- 折叠
摘要
Abstract
Objective To improve the product quality control of idarubicin hydrochloride. Methods The separation was performed on a C18 column with a mixture of methanol and 0. 1% phosphoric acid solution ( 57 :43 ) . The UV detection wavelength was 254 nm. Results A new impurity was found by an improved HPLC method for related substance in idarubicin hydrochloride, and the content rate of the new impurity found in the samples from marketing was as high as 1. 0%. Conclusion The new found impurity can directly affect the quality of the product.关键词
盐酸伊达比星/有关物质/新杂质Key words
idarubicin hydrochloride/related substance/new Impurity分类
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陈爽,张舒..盐酸伊达比星有关物质研究的新发现[J].中国药业,2016,25(17):29-30,31,3.