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Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection
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Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU
Chinese Journal of New Drugs | 2021, 30(14) : 1334 - 1339
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Chinese Journal of New Drugs | 2021, 30(14): 1334-1339
Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection
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Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU
Affiliations
  • National Institutes for Food and Drug Control, Beijing 102629, China
Published: 2021-07-30
Outline
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Objective:

To analyze polymer impurities in cefathiamidine for injection by different methods, and compare the advantages and disadvantages of the specificity of different methods.

Methods:

By using Sephadex G-10 System, high performance gel chromatography and column switching-LC-MSn method, the polymers in cefathiamidine for injection from 11 manufacturers were analyzed.

Results:

No polymer was detected by Sephadex G10 System, high performance gel chromatography could detect polymer impurities, the structure of the components separated by high performance gel chromatography system was confirmed by the column switching-LC-MSn method.

Conclusion:

It was proved that there were some polymer impurities in cefathiamidine for injection, the Sephadex G10 System and high performance gel chromatography had poor specificity, and macromolecular polymers and small molecular impurities could not be separated and qualitatively analyzed. This study laid the foundation to further establish a better specificity method.

cefathiamidine for injection  /  polymer  /  the column switching-LC-MSn
崇小萌, 田冶, 姚尚辰, 尹利辉, 刘颖, 许明哲. 注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析. 中国新药杂志, 2021 , 30 (14) : 1334 -1339 .
Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU. Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1334 -1339 .
Year 2021 volume 30 Issue 14
42
6
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  • Online Date:2026-10-28
  • Published:2021-07-30
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History
  • Accepted:2021-01-14
Affiliations
    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
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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