To analyze polymer impurities in cefathiamidine for injection by different methods, and compare the advantages and disadvantages of the specificity of different methods.
By using Sephadex G-10 System, high performance gel chromatography and column switching-LC-MSn method, the polymers in cefathiamidine for injection from 11 manufacturers were analyzed.
No polymer was detected by Sephadex G10 System, high performance gel chromatography could detect polymer impurities, the structure of the components separated by high performance gel chromatography system was confirmed by the column switching-LC-MSn method.
It was proved that there were some polymer impurities in cefathiamidine for injection, the Sephadex G10 System and high performance gel chromatography had poor specificity, and macromolecular polymers and small molecular impurities could not be separated and qualitatively analyzed. This study laid the foundation to further establish a better specificity method.
| 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 |