| 杨晨,谢益晖,王贺,顾德周,王林.磷酸左奥硝唑酯二钠细菌内毒素检测方法验证[J].中国药事,2019,33(8):944-948 |
| 磷酸左奥硝唑酯二钠细菌内毒素检测方法验证 |
| Validation of Bacterial Endotoxin Testing Method for Levoornidazole Phosphate Disodium |
| 投稿时间：2019-05-13 |
| DOI：10.16153/j.1002-7777.2019.08.015 |
| 中文关键词: 磷酸左奥硝唑酯二钠 细菌内毒素 凝胶法 干扰试验 |
| 英文关键词: levoornidazole phosphate disodium bacterial endotoxin gel method interference test |
| 基金项目: |
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| 中文摘要: |
| 目的：建立磷酸左奥硝唑酯二钠细菌内毒素的常规检测方法。方法：按《中华人民共和国药典》2015年版通则1143细菌内毒素检查法进行。结果：在验证条件下，样品原液稀释至6.25 mg·mL-1时，对细菌内毒素检查法无干扰作用。结论：建立的方法用于检查磷酸左奥硝唑酯二钠的细菌内毒素可行。 |
| 英文摘要: |
| Objective:To establish a conventional bacterial endotoxin testing method for levoornidazole phosphate disodium. Methods:The test method was carried out according to the bacterial endotoxin testing method of general rule 1143 in the Chinese Pharmacopoeia of 2015 edition. Results:Under the validation condition, the sample stock solution diluted to 6.25 mg·mL-1 did not interfere with the bacterial endotoxin testing. Conclusion:The established method can be used for bacterial endotoxin testing of levoornidazole phosphate disodium. |
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