原料药的杂质谱分析技术要点探析  

Discussion on the technical points of impurity profile analysis of synthetic drug substances

作　　者：赵玉[1] 王福生[1] 

机构地区：[1]华北制药集团新药研究开发有限责任公司,河北石家庄050015

出　　处：《煤炭与化工》2017年第7期150-152,共3页Coal and Chemical Industry

摘　　要：杂质作为药品的一项关键质量属性,其研究是贯穿于研发始终的一项重要系统工程。杂质谱分析是杂质研究工作的一项非常重要的工作,对指引药品制备工艺的研发和优化具有重要指导意义,只有在全面的进行杂质谱分析基础上,药品质量控制才能有的放矢;杂质谱分析同时也是杂质检查工作和建立合理可行检查方法的前提。根据几年来的药品研发工作经验,对化学合成原料药的杂质分析的一般原则、研究思路和实际工作情况进行梳理。Impurities as a key quality attribute of drugs, its research is an important system engineering throughout the research and development process of drugs, and the impurity spectrum analysis is a very important for research of impurity, and has a great guiding significance for the development and optimization of drug preparation process. Only on the basis of comprehensive impurity spectrum analysis, drug quality control could be targeted. The impurity spectrum analysis is also a prerequisite for impurity inspection work and the establishment of reasonable and feasible inspection methods. Based on the author＇s experience in drug research and development over the past few years, combining the general principles, research ideas and practical work of the chemical synthesis of raw materials were caredinged.

关 键 词：原料药 杂质 分析 

分 类 号：TQ460.7[化学工程—制药化工]