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Establishment of the first batch of national reference standard of rivaroxaban
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Qian LIU, Yu-fei FENG, Meng-jie QI, Dong-sheng YANG, Hao-yue GUAN, Jian-zhao NIU
Chinese Journal of New Drugs | 2023, 32(6) : 572 - 575
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Chinese Journal of New Drugs | 2023, 32(6): 572-575
Establishment of the first batch of national reference standard of rivaroxaban
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Qian LIU, Yu-fei FENG, Meng-jie QI, Dong-sheng YANG, Hao-yue GUAN, Jian-zhao NIU
Affiliations
  • National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2023-03-30
Outline
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Objective:

To establish the first batch of national reference standard of rivaroxaban.

Methods:

The structure of rivaroxaban was confirmed by IR, NMR and LC-MS spectroscopy. The purity of rivaroxaban was determined by HPLC. Moreover, moisture and residual ignition were determined. The content of rivaroxaban was calculated by mass balance method.

Results:

The structure of rivaroxaban was confirmed. The content of the first batch of national reference standard of rivaroxaban was assigned as 99.6%.

Conclusion:

The first batch of national reference standard of rivaroxaban can be applied for the identification and content determination of rivaroxaban and its related preparations.

rivaroxaban  /  certification of standard material  /  mass balance methods  /  reference substance  /  HPLC
Qian LIU, Yu-fei FENG, Meng-jie QI, Dong-sheng YANG, Hao-yue GUAN, Jian-zhao NIU. Establishment of the first batch of national reference standard of rivaroxaban[J]. Chinese Journal of New Drugs, 2023 , 32 (6) : 572 -575 .
Year 2023 volume 32 Issue 6
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Article Info
  • Online Date:2026-03-06
  • Published:2023-03-30
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History
  • Accepted:2022-09-23
Funding
Affiliations
    National Institutes for Food and Drug Control, Beijing 100050, 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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