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OBJECTIVE To establish a method for bacterial endotoxin test of active pharmaceutical ingredient (API) of insoluble adrenaline. METHODS According to the bacterial endotoxin test (BET) method in the general rule 1143 in the Chinese Pharmacopoeia (2020 Edition, Volume Ⅳ), adrenaline API was dissolved with hydrochloric acid and diluted with BET water. The gel method and kinetic turbidimetric assay were used to carry out interference test and endotoxin recovery interference verification test. RESULTS Adrenaline API was dissolved with 0.1 mol·L-1 hydrochloric acid to 10 mg·mL-1, and then diluted 200 times or more by BET water, which had no interference effects to bacterial endotoxin test. CONCLUSION The BET method established in this study can be used for the bacterial endotoxin test of adrenaline API of adrenaline to control the product quality.
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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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