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Determination of Main Carbohydrate Residues in Dextran 40 by HPLC-RID Method
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Shenggu XIE1, Zhuyu JIN1, 2, Xiao SUN1, Qiaoqiao HUANG3, *, Jinqi ZHENG1, *
Chinese Pharmaceutical Journal | 2024, 59(9) : 834 - 839
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Chinese Pharmaceutical Journal | 2024, 59(9): 834-839
Determination of Main Carbohydrate Residues in Dextran 40 by HPLC-RID Method
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Shenggu XIE1, Zhuyu JIN1, 2, Xiao SUN1, Qiaoqiao HUANG3, *, Jinqi ZHENG1, *
Affiliations
  • 1 NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
  • 2 China Pharmaceutical University, Nanjing 211198, China
  • 3 Zhejiang Medical Device Evaluation Center, Hangzhou 310001, China
Published: 2024-05-08 doi: 10.11669/cpj.2024.09.009
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OBJECTIVE To establish a high performance liquid chromatography-refractive index detector method for the determination of main potential carbohydrate residues fructose and sucrose concentration in dextran 40 raw materials from different of production processes, analyze the differences in carbohydrate residues in dextran 40 produced by different manufactures, and provide a reference for the quality evaluation of related drugs and the formulation or edit of national drug standards. METHODS Isocratic elution was performed on a ZORBAX-NH2 column. Mobile phase consisted of 75% acetonitrile and 25% water at a flow rate of 1.0 mL·min-1. RID was used as detector. The detector temperature and column temperature was maintained at 40 ℃ and the injection volume was 50 μL. RESULTS Sucrose was not detected in all batches of dextran 40. Fructose residue could only be detected in dextran 40 which using alcohol precipitation production process, and the content was 0.005%-0.14%. No fructose residue was detected in the dextran 40 of manufacturer B using membrane filtration method. CONCLUSION The HPLC-RID method is established to determine the content of fructose and sucrose in dextran 40. The method has strong specificity, high sensitivity, good stability and simple operation. The amount of fructose residual in dextran 40 produced by different processes varies greatly. The fructose residual in the raw material of dextran 40 obtained by membrane filtration is significantly lower than that by alcohol precipitation, it is necessary to control the fructose residue in the quality standard.

Dextran 40  /  HPLC-RID  /  production process  /  quality control  /  fructose residue
Shenggu XIE, Zhuyu JIN, Xiao SUN, Qiaoqiao HUANG, Jinqi ZHENG. Determination of Main Carbohydrate Residues in Dextran 40 by HPLC-RID Method[J]. Chinese Pharmaceutical Journal, 2024 , 59 (9) : 834 -839 . DOI: 10.11669/cpj.2024.09.009
Year 2024 volume 59 Issue 9
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doi: 10.11669/cpj.2024.09.009
  • Receive Date:2023-08-21
  • Online Date:2025-11-25
  • Published:2024-05-08
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  • Received:2023-08-21
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Affiliations
    1 NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
    2 China Pharmaceutical University, Nanjing 211198, China
    3 Zhejiang Medical Device Evaluation Center, Hangzhou 310001, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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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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