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To develop the national reference standards of 1,1,1,2-tetrafluoroethane as the excipient of medicinal aerosol and its impurities thus to improve the standard of quality control.
The national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were sub-packaged in liquid state directly. The structures were confirmed by IR, MS and MR spectroscopy, the moisture was determined by Coulomb method, the tightness of the package was confirmed by immersion in water. The content of each substance was calculated by mass balance method．Homogeneity and stability were investigated by F test and linear fitting respectively, and the content of 1,1,1,2-tetrafluoroethane was confirmed by multiple laboratories simultaneously.
The contents of 1,1,1,2-tetrafluoroethane, 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were 100.0%, 99.9%, 99.7%, 99.2%, and 99.9%, respectively, with good homogeneity and stability.
In this study, the national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities were developed for the first time, where 1,1,1,2-tetrafluoroethane can be applied for content determination, and the other substances can be applied for the inspection of related substances.
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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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