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Application of an HPLC correction factor method in pharmaceutical analysis
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Ting XIAO, Chen WANG, Shang-chen YAO, Yan-chun FENG*, Chang-qin HU*
Acta Pharmaceutica Sinica | 2020, 55(12) : 2854 - 2861
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Acta Pharmaceutica Sinica | 2020, 55(12): 2854-2861
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Application of an HPLC correction factor method in pharmaceutical analysis
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Ting XIAO, Chen WANG, Shang-chen YAO, Yan-chun FENG*, Chang-qin HU*
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  • National Institutes for Food and Drug Control, Beijing 102629, China
Published: 2020-12-12 doi: 10.16438/j.0513-4870.2020-0697
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With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.

HPLC  /  correction factor  /  response factor  /  main component self-contrast method  /  substitute reference substance method
Ting XIAO, Chen WANG, Shang-chen YAO, Yan-chun FENG, Chang-qin HU. Application of an HPLC correction factor method in pharmaceutical analysis[J]. Acta Pharmaceutica Sinica, 2020 , 55 (12) : 2854 -2861 . DOI: 10.16438/j.0513-4870.2020-0697
Year 2020 volume 55 Issue 12
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doi: 10.16438/j.0513-4870.2020-0697
  • Receive Date:2020-05-07
  • Online Date:2026-01-23
  • Published:2020-12-12
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  • Received:2020-05-07
  • Revised:2020-07-07
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    National Institutes for Food and Drug Control, Beijing 102629, 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
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种数
Number of
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占总种数比例
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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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