随着药物研发技术和检测方法的快速发展，各国均制定了杂质或有害物质残留控制的指导原则。遵循“建立研究目标→确立杂质检测方法→样品检测→综合评价→建立限度并进行控制”的研究思路，根据杂质的不同来源、杂质的危害性、过程中去除的难易等因素来确定其在终产品中是否定入质量标准。从以上几方面综述了近年来药物中杂质及有害物质控制限度的研究进展。

Along with the rapid development of the drug research technology and detection methods, many guidelines were introduced focusing on impurities or hazardous substances residual in drugs by various countries. According to the procedure "establish the study target → develop the impurities testing method → sample determination → overall evaluation → setting limit and control", the impurities may be evaluated whether to control in final products within the different factors, such as impurity sources, impurity harmfulness, removal difficulty from the final product, etc. Research progress on quality control of impurities or hazardous substances in drugs are summarized in this paper from above aspects.

国家科技重大专项资助项目（2014ZX09201022-004）