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Establishment of the first batch of national reference standards for bivalirudin
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Li-ping REN, Lan-ying HE, Hai-ming LIAO, Jin WANG, Hong-miao YANG, Hui-hong FAN**
Chinese Journal of Pharmaceutical Analysis | 2025, 45(5) : 851 - 858
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Chinese Journal of Pharmaceutical Analysis | 2025, 45(5): 851-858
• Ingredient Analysis •
Establishment of the first batch of national reference standards for bivalirudin
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Li-ping REN, Lan-ying HE, Hai-ming LIAO, Jin WANG, Hong-miao YANG, Hui-hong FAN**
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  • National institutes for Food and Drug Control, Beijing 102629, China
doi: 10.16155/j.0254-1793.2024-0274
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Objective: To develop the first national reference standards for the quantitative determination of bivalirudin,in order to effectively control the product quality of bivalirudin injections, and to explore alternative methods for the quantitative characterization of synthetic peptide reference materials. Methods: Infrared (IR) spectroscopy, UV spectroscopy, HPLC, MS were used to confirm the structure of bivalirudin. Related substance were analyzed by HPLC.The mass balance method was used to determine the content of bivalirudin, which was further verified by a peptide content assay corrected for related peptide impurities. In addition, the stability and uniformity of the candidate reference material were evaluated. Results: The content of the first batch of bivalirudin national reference standard was 88.8%,calculated on C98H138N24O33, and the stability and uniformity tests met the required specifications. Conclusion: Based on the structural characteristics of the synthetic peptides, multiple qualitative and quantitative methods were used to ensure the accuracy of the content assignment for the national reference standard of bivalirudin.

bivalirudin  /  national reference standard  /  mass balance method  /  assay
Li-ping REN, Lan-ying HE, Hai-ming LIAO, Jin WANG, Hong-miao YANG, Hui-hong FAN. Establishment of the first batch of national reference standards for bivalirudin[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45 (5) : 851 -858 . DOI: 10.16155/j.0254-1793.2024-0274
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Year 2025 volume 45 Issue 5
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doi: 10.16155/j.0254-1793.2024-0274
  • Receive Date：2024-04-24
  • Online Date：2025-12-12
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  • Received：2024-04-24
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    National institutes for Food and Drug Control, Beijing 102629, China
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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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