隨著藥物研發(fā)技術和檢測方法的快速發(fā)展，各國均制定了雜質或有害物質殘留控制的指導原則。遵循“建立研究目標→確立雜質檢測方法→樣品檢測→綜合評價→建立限度并進行控制”的研究思路，根據雜質的不同來源、雜質的危害性、過程中去除的難易等因素來確定其在終產品中是否定入質量標準。從以上幾方面綜述了近年來藥物中雜質及有害物質控制限度的研究進展。

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.

國家科技重大專項資助項目（2014ZX09201022-004）