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Establishment of the first batch of national drug reference standard of L-methionine sulfoxide
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Jing-kun LIU, Dou-sheng ZHANG, Hui-hong FAN, Hai-ming LIAO**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(8) : 1373 - 1378
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(8): 1373-1378
Bioassay
Establishment of the first batch of national drug reference standard of L-methionine sulfoxide
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Jing-kun LIU, Dou-sheng ZHANG, Hui-hong FAN, Hai-ming LIAO**
Affiliations
  • National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China
Published: 2024-08-31 doi: 10.16155/j.0254-1793.2023-0311
Outline
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Objective:

To establish the first batch of national drug reference standard of L-methionine sulfoxide.

Methods:

The molecular structure of methionine sulfoxide was confirmed by the methods of IR,NMR and high resolution MS. Moreover,the moisture,residual solvents,residual ignition and related substances of L-methionine sulfoxide were determined,and then,its hygroscopicity,homogeneity and stability were also observed. Finally,mass balance method,HPLC and quantitative NMR were applied to determine and calculate its contents.

Results:

The results of experiments showed the structure of L-methionine sulfoxide were confirmed,its contents of moisture,residual ignition,metal elements and related substances were 0.23%,0.20%,10.87 μg·g-1 and 5.09%. The residual solvents were not detected in the samples. The final content of methionine sulfoxide was 94.5% by mass balance method. The contents of this batch of L-methionine sulfoxide were uniform,and it is stable in short-terms.

Conclusion:

The first batch of national drug reference standard of L-methionine sulfoxide was established,and it is used for the inspection for related substances of amino acid drug,which is helpful in normalizing drug quality and guaranteeing drug safety.

L-methionine sulfoxide  /  reference standard  /  structure confirmation  /  related substances  /  mass balance method
Jing-kun LIU, Dou-sheng ZHANG, Hui-hong FAN, Hai-ming LIAO. Establishment of the first batch of national drug reference standard of L-methionine sulfoxide[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (8) : 1373 -1378 . DOI: 10.16155/j.0254-1793.2023-0311
Year 2024 volume 44 Issue 8
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doi: 10.16155/j.0254-1793.2023-0311
  • Receive Date:2023-05-18
  • Online Date:2026-03-13
  • Published:2024-08-31
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  • Received:2023-05-18
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    National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,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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