Full
Outline
To explore the internal factors affecting the quality of cefotiam hydrochloride for injection.
The routine quality items of cefotiam hydrochloride for injection products from different manufactures were evaluated, and the thermal stability was compared. The degradation impurities were analyzed using column switching LC-MS, the crystal forms of products with different manufactures were compared by powder X diffraction method, the particle size distribution of the products was determined by light scattering method, and TGA and near infrared spectroscopy were used to predict the binding mode of water.
The differences of the routine quality among the products from different manufacturers were small, but the thermal stability and internal quality showed significant differences.
The main internal factors affecting the thermal stability of cefotiam hydrochloride for injection were crystal size distribution and sodium carbonate content. The evaluation of product quality should start with its internal quality, so as to evaluate the advantages and disadvantages of the production process.
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| 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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