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Establishment of national reference standard of caspofungin acetate
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Jia-ning ZHANG1, 2, Bu-fang MA3, Bin LI1, 2, 4, Yong-xiang LIU1, 2, 4, An-ni DONG1, 2, 4, Min YU1, 2, *, Ye TIAN1, 2, *
Chinese Journal of New Drugs | 2026, 35(19) : 2113 - 2119
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Chinese Journal of New Drugs | 2026, 35(19): 2113-2119
Establishment of national reference standard of caspofungin acetate
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Jia-ning ZHANG1, 2, Bu-fang MA3, Bin LI1, 2, 4, Yong-xiang LIU1, 2, 4, An-ni DONG1, 2, 4, Min YU1, 2, *, Ye TIAN1, 2, *
Affiliations
  • 1 Institute for Safety Evaluation, National Institutes for Drug Control, Beijing 100176, China
  • 2 State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
  • 3 Institute for Chemical Drug Control, National Institutes for Drug Control, Beijing 102629, China
  • 4 Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.013
Outline
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Objective:

This study successfully developed the first batch of national reference standards of caspofungin acetate to ensure quality control of related raw materials and finished products.

Methods:

The structure of the caspofungin acetate reference standard was confirmed by comprehensive analytical techniques including high-resolution mass spectrometry (HRMS), nuclear magnetic resonance (NMR), and infrared spectroscopy (IR), and the NMR signals of the compound were assigned. The content of caspofungin acetate was determined by the mass balance method (MBM), and the results were corroborated by quantitative nuclear magnetic resonance (qNMR) and the external standard method (ESM).

Results:

The content of this batch of caspofungin acetate reference standard, calculated as C52H88N10O15·2CH3COOH, was 97.0%.

Conclusion:

The first batch of national reference standards of caspofungin acetate was successfully developed.

caspofungin acetate  /  reference standard  /  quality control  /  NMR  /  mass balance method
张佳宁, 马步芳, 李彬, 刘永祥, 董安妮, 于敏, 田冶. 醋酸卡泊芬净标准物质的研制. 中国新药杂志, 2026 , 35 (19) : 2113 -2119 . DOI: 10.20251/j.cnki.1003-3734.2026.19.013
Jia-ning ZHANG, Bu-fang MA, Bin LI, Yong-xiang LIU, An-ni DONG, Min YU, Ye TIAN. Establishment of national reference standard of caspofungin acetate[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2113 -2119 . DOI: 10.20251/j.cnki.1003-3734.2026.19.013
Appendix
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Year 2026 volume 35 Issue 19
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.19.013
  • Receive Date：2026-04-18
  • Online Date：2026-10-29
  • Published：2026-10-15
Article Data
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History
  • Received：2026-04-18
Affiliations
    1 Institute for Safety Evaluation, National Institutes for Drug Control, Beijing 100176, China
    2 State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
    3 Institute for Chemical Drug Control, National Institutes for Drug Control, Beijing 102629, China
    4 Shenyang Pharmaceutical University, Shenyang 110016, China
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https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2026.19.013
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表12种不同金属材料的力学参数
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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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