硫酸特布他林原料药细菌内毒素检查方法学研究

Investigation on bacterial endotoxins test of terbutaline sulfate active pharmaceutical gredient

王新宇 ¹刘振华 ²卢海霞 ¹张昦昉¹

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作者信息

1. 吉林省药品检验研究院,长春 130033
2. 长春中医药大学附属第三临床医院心血管内科,长春 130118
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摘要

目的:建立硫酸特布他林原料药细菌内毒素的检查方法.方法:采用凝胶法对硫酸特布他林进行方法学验证,并对三批样品进行了干扰试验和细菌内毒素检查.结果:可用于细菌内毒素检查的硫酸特布他林原料药,限值定为"每1 mg硫酸特布他林中含内毒素的量应小于0.50 EU".结论:鲎试剂凝胶法可用于硫酸特布他林原料药细菌内毒素检查.

Abstract

Objective:To establish a method for the detection of bacterial endotoxin in terbutaline sulfate active pharmaceutical ingredients(API).Methods:The method of terbutaline sulfate was verified by gel method,and interference test and bacterial endotoxin test were performed on three batches of samples.Results:The limit for terbutaline sulfate API that can be used for bacterial endotoxin test was set as"the amount of endotoxin contained in terbutaline sulfate should be less than 0.50 EU per 1 mg".Conclusion:Limulus gel method can be used to detect bacterial endotoxin of terbutaline sulfate API.

关键词

硫酸特布他林/原料药/细菌内毒素/干扰试验/凝胶法

Key words

terbutaline sulfate/active pharmaceutical ingredient/bacterial endotoxins test/interference test/gel method

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出版年

2024

中国药品标准

国家药典委员会

中国药品标准

影响因子：0.372

ISSN：1009-3656

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