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Study on the structure of an unknown impurity in carboplatin injection and the relationship with the excipient
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Wei JIN, Wen-ming JIANG, Qian LIU, Xuan GAO, Ye ZHANG, Dan GUO, Min QIAN, Mei-ting REN, Yong-jian YANG*
Acta Pharmaceutica Sinica | 2018, 53(4) : 604 - 608
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Acta Pharmaceutica Sinica | 2018, 53(4): 604-608
• ORIGINAL ARTICLES·Pharmaceutical Analysis •
Study on the structure of an unknown impurity in carboplatin injection and the relationship with the excipient
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Wei JIN, Wen-ming JIANG, Qian LIU, Xuan GAO, Ye ZHANG, Dan GUO, Min QIAN, Mei-ting REN, Yong-jian YANG*
Affiliations
  • Shanghai Institute for Food and Drug Control, Shanghai 201203, China
Published: 2018-04-12 doi: 10.16438/j.0513-4870.2017-1126
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The study was designed to establish a 2D UPLC-QTOF method to extrapolate the structure of an unknown substance in carboplatin injection and its relationship with the excipient. By using phenyl-hexyl column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of tetrabutylammonium sulfate buffer (pH 7.5) and acetonitrile in gradient elution mode, an unknown impurity in carboplatin injection was found and quantitatively determined. Then a 2D UPLC-QTOF, HSS T3 column (100 mm×2.1 mm, 1.7 μm) was employed to confirm the molecular weight and the structure of the unknown impurity (electrospray ionization source, positive ion mode, MSE mode) with mobile phase consisting of 0.1% formic acid and acetonitrile. The relationship among impurities, API and excipient was investigated by accelerated stability test with ICP-MS/MS, ICP-AES. Results showed that disodium edetate in the formulation interacted with carboplatin producing an unknown impurity containing platin, and induced the increase of 1, 1-cyclobutanedicarboxylic acid. The research should be done on the rationality of the addition of disodium edetate in such injections containing heavy metals.

carboplatin injection  /  impurity containing platin  /  disodium edentate  /  1, 1-cyclobutanedicarboxylic acid  /  2D-LC-MS-QTOF
Wei JIN, Wen-ming JIANG, Qian LIU, Xuan GAO, Ye ZHANG, Dan GUO, Min QIAN, Mei-ting REN, Yong-jian YANG. Study on the structure of an unknown impurity in carboplatin injection and the relationship with the excipient[J]. Acta Pharmaceutica Sinica, 2018 , 53 (4) : 604 -608 . DOI: 10.16438/j.0513-4870.2017-1126
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Article Info
doi: 10.16438/j.0513-4870.2017-1126
  • Receive Date：2017-11-14
  • Online Date：2026-01-15
  • Published：2018-04-12
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  • Received：2017-11-14
  • Revised：2018-01-09
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    Shanghai Institute for Food and Drug Control, Shanghai 201203, 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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