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Identification of impurity profile in tinidazole glucose injection by UPLC-MS
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Jing-jing WANG1, Wei-feng DU2, Xing-hong WEI2, Zi-li XIE2, *, Jie CHENG2, *
Acta Pharmaceutica Sinica | 2019, 54(9) : 1655 - 1660
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Acta Pharmaceutica Sinica | 2019, 54(9): 1655-1660
• Original Articles •
Identification of impurity profile in tinidazole glucose injection by UPLC-MS
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Jing-jing WANG1, Wei-feng DU2, Xing-hong WEI2, Zi-li XIE2, *, Jie CHENG2, *
Affiliations
  • 1. Anhui University of Chinese Medicine, Hefei 230038, China
  • 2. Anhui Institute for Food and Drug Control, Hefei 230051, China
Published: 2019-09-12 doi: 10.16438/j.0513-4870.2019-0278
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Five components in the impurity profile of tinidazole glucose injection were detected and identified by UPLC-Q Exactive quadrupole-electrostatic field orbitrap high resolution mass spectrometry, in combination with retention time references, organic reaction mechanisms and UV spectral analysis. They are 2-methyl-5-nitroimidazole (impurity 1), 5-hydroxymethylfurfural (impurity 2), 1-(2-(ethylsulfonyl)ethyl)-2-methyl-4-nitro-1H-Imidazole (impurity 5), 1-(2-(ethylthio)ethyl)-2-methyl-5-nitro-1H-imidazole (impurity 6) and 1, 4-di-N-oxo-2-methyl-5-nitro-1H-imidazole (impurity 8) respectively, of which impurities 6 and 8 are identified for the first time. These results and detection methods are useful for monitoring the manufacturing process and quality control of tinidazole and glucose injection solution.

tinidazole and glucose injection  /  organic impurity  /  UPLC-MS  /  structure identification
Jing-jing WANG, Wei-feng DU, Xing-hong WEI, Zi-li XIE, Jie CHENG. Identification of impurity profile in tinidazole glucose injection by UPLC-MS[J]. Acta Pharmaceutica Sinica, 2019 , 54 (9) : 1655 -1660 . DOI: 10.16438/j.0513-4870.2019-0278
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Article Info
doi: 10.16438/j.0513-4870.2019-0278
  • Receive Date：2019-04-12
  • Online Date：2026-01-26
  • Published：2019-09-12
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  • Received：2019-04-12
  • Revised：2019-06-02
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Affiliations
    1. Anhui University of Chinese Medicine, Hefei 230038, China
    2. Anhui Institute for Food and Drug Control, Hefei 230051, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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Genus		 种数
Number of
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Percentage of total
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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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