| 高新贞,吕文丽,刘枕,王彦厚.磷酸氟达拉滨细菌内毒素检查方法的建立[J].中国药品标准,2018,19(1):28-31 |
| 磷酸氟达拉滨细菌内毒素检查方法的建立 |
| Establishment of Bacterial Endotoxin Test Method for Fludarabine Phosphate |
| 投稿时间：2017-09-26 修订日期：2018-02-09 |
| DOI： |
| 中文关键词: 磷酸氟达拉滨 细菌内毒素 凝胶法 方法学 干扰试验 |
| 英文关键词: fludarabine phosphate bacterial endotoxins gel-clot technique methodology test for interfering factors |
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| 摘要点击次数: 700 |
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| 中文摘要: |
| 目的 建立磷酸氟达拉滨细菌内毒素检查方法。方法 按《中国药典》2015年版四部1143细菌内毒素凝胶检查法的要求,通过干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果 0.27mg.mL-1及以下浓度,不干扰内毒素和鲎试剂的反应。结论 可以采用此法对磷酸氟达拉滨的细菌内毒素进行检查。 |
| 英文摘要: |
| Objective To establish bacterial endotoxin test method of fludarabine phosphate. Methods Determine the maximum concentration of sample solution by test for interfering factors and verify it, according to the requirements of Pharmacopoeia of the People’s Republic of China (2015) volume Ⅳ 1143 bacterial endotoxins test. Results There is no interference of the clotting of tachypleus amebocyte lysate in the presence of endotoxin while concentration of sample solution is not more than 0.27mg.ml-1. Conclusion This method can be used in the bacterial endotoxins test of fludarabine phosphate. |
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