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OBJECTIVE To establish the first batch of national reference standard for quantitative and qualitative analysis of vortioxetine hydrobromide. METHODS The structure of vortioxetine hydrobromide was identified by means of 1H-NMR, 13C-NMR, MS, IR and UV. HPLC purity was calculated via peak area normalization and principal component self-comparison. The homogeneity and stability were studied by HPLC, and other physicochemical properties were investigated using various analytical methods. The content was determined using mass balance method and verified by NMR quantitative method and differential scanning calorimetry. RESULTS The structure of the first batch of national reference substance of vortioxetine hydrobromide was confirmed and its content was determined to be 99.9%. CONCLUSION The development of the first batch of national reference substance of vortioxetine hydrobromide can meet the quality control requirements of raw material and preparations of vortioxetine hydrobromide.
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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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