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Current situation and the trend in impurity profiling of chemical drugs
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Chang-qin HU*, Xia ZHANG
Acta Pharmaceutica Sinica | 2019, 54(12) : 2214 - 2231
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Acta Pharmaceutica Sinica | 2019, 54(12): 2214-2231
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Current situation and the trend in impurity profiling of chemical drugs
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Chang-qin HU*, Xia ZHANG
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  • National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2019-12-12 doi: 10.16438/j.0513-4870.2019-0451
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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.

impurity profile  /  chemical drug  /  impurity identification  /  impurity assessment  /  pharmaceutical standard
Chang-qin HU, Xia ZHANG. Current situation and the trend in impurity profiling of chemical drugs[J]. Acta Pharmaceutica Sinica, 2019 , 54 (12) : 2214 -2231 . DOI: 10.16438/j.0513-4870.2019-0451
Year 2019 volume 54 Issue 12
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Article Info
doi: 10.16438/j.0513-4870.2019-0451
  • Receive Date:2019-06-07
  • Online Date:2026-01-26
  • Published:2019-12-12
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  • Received:2019-06-07
  • Revised:2019-09-06
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    National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数

Family
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Number of
genus
种数
Number of
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占总种数比例
Percentage of
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种数
Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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