||药学学报, 2019, 54(12): 2214-2231
||胡昌勤, 张夏. 化学药品杂质谱控制的现状与展望[J]. 药学学报, 2019, 54(12): 2214-2231.
||HU Chang-qin, ZHANG Xia. Current situation and the trend in impurity profiling of chemical drugs[J]. Acta Pharmaceutica Sinica, 2019, 54(12): 2214-2231.
|中国食品药品检定研究院, 北京 100050
|Current situation and the trend in impurity profiling of chemical drugs
|HU Chang-qin, ZHANG Xia
|National Institutes for Food and Drug Control, Beijing 100050, China
|Impurity profiling is one of the most important activities in both assuring drug safety and improving the quality of domestic drugs. Since the basic strategy of impurity profile control was put forward in 2010, a mature control procedure for impurity profile in drugs has been formed in China after nearly ten years of continuous efforts. The progress in impurity profiling before 2010 and from 2010 to 2015 have been reviewed. Since 2015, the concepts, analytical techniques and the application of these techniques in this field have developed rapidly. As a result, the progress in impurity profiling of chemical drugs since 2015 was reviewed in this paper. And the views on future development of impurity profiling in drugs were also put forward.
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