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Determination method of deamidation impurities in cobratide using mass spectrometry technique
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Lu HUANG1, 2, Bo LIU1, 2, Hui-hong FAN1, 2, *
Acta Pharmaceutica Sinica | 2021, 56(9) : 2352 - 2359
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Acta Pharmaceutica Sinica | 2021, 56(9): 2352-2359
• Special Reports: Bioanalysis for Drug •
Determination method of deamidation impurities in cobratide using mass spectrometry technique
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Lu HUANG1, 2, Bo LIU1, 2, Hui-hong FAN1, 2, *
Affiliations
  • 1. National Institutes for Food and Drug Control, Beijing 100050, China
  • 2. NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China
Published: 2021-09-12 doi: 10.16438/j.0513-4870.2021-0619
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Deamidation is one of the most common degradation impurities in protein and peptide drugs. The deamidation of glutamine and asparagine in the protein sequence can lead to changes in the chemical and biological properties of the protein. However, the rutine trypsin-based pretreatment process can significantly increase the artificial deamidation impurities during the digestion process, resulting in high determination level. In this study, after optimizing the conditions of Glu-C enzymatic hydrolysis, we obtained the best enzymatic conditions under acidic condition and the artificial deamidation impurities significantly reduced in digestion process, identified the deamidation site (N48). Through the methodological investigation and comparison of the measurement results of different methods, the specificity, reproducibility and accuracy of the method are verified. The method established in this research has laid a solid foundation for the accurate determination of deamidation impurities in cobratide and its similar protein peptide biochemical drugs.

cobratide  /  Glu-C enzyme  /  deamidation  /  accurate determination  /  biological mass spectrometry
Lu HUANG, Bo LIU, Hui-hong FAN. Determination method of deamidation impurities in cobratide using mass spectrometry technique[J]. Acta Pharmaceutica Sinica, 2021 , 56 (9) : 2352 -2359 . DOI: 10.16438/j.0513-4870.2021-0619
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Article Info
doi: 10.16438/j.0513-4870.2021-0619
  • Receive Date：2021-04-25
  • Online Date：2025-12-18
  • Published：2021-09-12
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History
  • Received：2021-04-25
  • Revised：2021-07-15
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    1. National Institutes for Food and Drug Control, Beijing 100050, China
    2. 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
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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