新药中特殊杂质的分析研究进展
肖莹,倪坤仪
中国药科大学 南京210038
[文摘]本文综述了新药中特殊杂质的来源，比较了几种常用色谱法在测定有关物质中的应用，并阐述了特殊杂质进行结构分析的意义和主要测定步骤。其中HPLC/NMR在杂质测定方面有较好的应用前景。
[关键词]新药；特殊杂质；色谱法
Study of Specified Impurity in Drug
Xiaoying Nikunyi
China Pharmaceutical University , Nanjing 210038
Abstract: The article discussed the resource of the specified impurities in new drug, and compared the applications of chromatographic methods in the determination of drug-related substances. And it explained the importance of structure analysis on specified impurities. Among this article HPLC/NMR had great application prospect in determining impurities.
Keywords: New drug; Specified impurity; Chromatography
, 百拇医药
中国药科大学 南京210038
[文摘]本文综述了新药中特殊杂质的来源，比较了几种常用色谱法在测定有关物质中的应用，并阐述了特殊杂质进行结构分析的意义和主要测定步骤。其中HPLC/NMR在杂质测定方面有较好的应用前景。
[关键词]新药；特殊杂质；色谱法
Study of Specified Impurity in Drug
Xiaoying Nikunyi
China Pharmaceutical University , Nanjing 210038
Abstract: The article discussed the resource of the specified impurities in new drug, and compared the applications of chromatographic methods in the determination of drug-related substances. And it explained the importance of structure analysis on specified impurities. Among this article HPLC/NMR had great application prospect in determining impurities.
Keywords: New drug; Specified impurity; Chromatography
, 百拇医药