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Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS
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Jian ZOU, Lei YANG, Tao LIN, Jue-xiao WANG, Jin MA, Jie CHEN, Yan LI*
Chinese Journal of Pharmaceutical Analysis | 2024, 44(2) : 256 - 263
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(2): 256-263
Bioassay·Activity Analysis
Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS
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Jian ZOU, Lei YANG, Tao LIN, Jue-xiao WANG, Jin MA, Jie CHEN, Yan LI*
Affiliations
  • Sichuan Institute for Drug Control, NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products,Chengdu 610097,China
Published: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.08
Outline
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Objective:

To establish a method for determining molecular weight and distribution of raw mannatide and its preparation with SEC-RI-MALLS.

Methods:

Specificity,accuracy, precision and robustness of SEC-RI-MALLS method was verified by performing on a Shodex OHpak SB-804 HQ column with 0.05 mol·L-1 sodium sulfate buffer as mobile phase at a flow rate of 0.5 mL·min-1 and a comparison between SEC-RI-MALLS and GPC was studied too.

Resulst:

The tablet excipient starch had no interference to the test. The relative accuracy error between the measured value and the labeled value of dextran standard was less than 3.0%. RSD of precision was 0.40% when the sample concentration was 2 mg·mL-1 and the RSD of reproducibility and robustness were less than 5.0%. There was no significant difference between Shodex OHpak SB-804 HQ column and TSK-GEL G4000 PWXL column by comparing the results of 79 batches of samples. Compared with the national standard method (GPC) for molecular weight determination, the molecular weight of SEC-RI-MALLS method was 19 509 Da higher on average, and the molecular weight distribution was more concentrated.

Conclusion:

SEC-RI-MALLS method can determine the molecular weight and distribution of mannatide without standard with good accuracy and robustness. Compared with the existing method, SEC-RI-MALLS method is more conducive to the safety and effectiveness control of the variety.

multi-angle laser light scattering  /  size exclusion chromatography  /  gel permeation chromatography  /  mannatide  /  molecular weight and distribution
Jian ZOU, Lei YANG, Tao LIN, Jue-xiao WANG, Jin MA, Jie CHEN, Yan LI. Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 256 -263 . DOI: 10.16155/j.0254-1793.2024.02.08
Year 2024 volume 44 Issue 2
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doi: 10.16155/j.0254-1793.2024.02.08
  • Online Date:2026-03-13
  • Published:2024-02-29
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  • Revised:2023-10-11
Affiliations
    Sichuan Institute for Drug Control, NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products,Chengdu 610097,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
total species (%)

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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