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目的验证2010年能力验证盲样样品细菌内毒素检查法的可行性。方法参照《中国药典》2010年版二部附录ⅪE试验方法,通过干扰/确证试验来确定盲样冻干粉的有效稀释浓度和细菌内毒素检查限值。结果盲样冻干粉的200倍稀释溶液无干扰作用,其细菌内毒素限值符合规定。结论盲样冻干粉可以通过细菌内毒素检查法来检查其细菌内毒素含量。
Objective To verify the feasibility of bacterial endotoxin test in 2010 proficiency blind samples. Methods According to the “Chinese Pharmacopoeia” 2010 edition two appendix ⅪE test method, by interference / confirmatory test to determine the effective dilution of the blind sample of lyophilized powder and bacterial endotoxin test limits. Results Blind-like lyophilized powder 200 times diluted solution without interference, the bacterial endotoxin limits in line with the provisions. Conclusion Blind samples of lyophilized bacteria can be checked by bacterial endotoxin test bacterial endotoxin content.