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Determination the content of sodium caprylate in human blood albumin products by ion chromatography*
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Cui-xia YAN1, Fang-liang SHI1, Chun-xia HAN2, Xin-xin FANG1, Lu-xia ZHENG1, Hong SHAO1, **
Chinese Journal of Pharmaceutical Analysis | 2024, 44(2) : 249 - 255
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(2): 249-255
Bioassay·Activity Analysis
Determination the content of sodium caprylate in human blood albumin products by ion chromatography*
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Cui-xia YAN1, Fang-liang SHI1, Chun-xia HAN2, Xin-xin FANG1, Lu-xia ZHENG1, Hong SHAO1, **
Affiliations
  • 1.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
  • 2.Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201203, China
Published: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.07
Outline
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Objective:

To establish an ion chromatography method for determination the content of sodium caprylate in human blood albumin products.

Methods:

The samples were precipitated with eluent, the suspension was centrifuged and filtered, the filtrate was injected to IC, and heptanoic acid was used as the internal standard. A Dionex InPacTM NS1 Analytical Column (250 mm×4mm, 10 μm) and a Dionex InPacTM NG1 Guard Column (35 mm×4 mm, 10 μm) were used,the flow rate was 1.0 mL·min-1. The conductivity detector and ASRS 300 membrane suppressor were used, and the regenerant solution was 5 mmol·L-1 tetrabutylsodium hydroxide solution; the column temperature was 30 ℃ and the injection volume was 25 μL.

Results:

The resolution between the peaks of sodium caprylate and the internal standard was greater than 1.5, and the linearity of concentration of sodium caprylate was good in the range of 0.38-2.52 mmol·L-1, r=0.999 5 (n=6). The RSD of the repeatability test was 1.1% (n=6). The average recovery was 97.4% and RSD was 1.8% (n=9). The limits of quantification and detection were 0.19 nmol and 0.09 nmol, respectively. The determination results of the content of sodium octanoate in 20 batches of human blood albumin samples from 7 enterprises at home and abroad ranged from 0.073-0.163 mmol·g-1.

Conclusion:

The method established in this study is simple to operate, accurate in results, high in sensitivity and good in repeatability, can be used for the determination of sodium caprylate content in human blood albumin products and provide a method guarantee for its quality control.

ion chromatography  /  internal standard method  /  sodium caprylate  /  human blood albumin  /  quality control
Cui-xia YAN, Fang-liang SHI, Chun-xia HAN, Xin-xin FANG, Lu-xia ZHENG, Hong SHAO. Determination the content of sodium caprylate in human blood albumin products by ion chromatography*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 249 -255 . DOI: 10.16155/j.0254-1793.2024.02.07
Year 2024 volume 44 Issue 2
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Article Info
doi: 10.16155/j.0254-1793.2024.02.07
  • Receive Date:2023-05-30
  • Online Date:2026-03-13
  • Published:2024-02-29
Article Data
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History
  • Received:2023-05-30
Funding
Affiliations
    1.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
    2.Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201203, 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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