总有机碳(TOC)在注射液清洁验证中的应用

Application of Total Organic Carbon Analysis (TOC) in Cleaning Validation of Injection

目的:考察总有机碳(TOC)在硫酸依替米星氯化钠注射液清洁验证中的适用性。方法:通过对检测方法的灵敏度和可操作性等方面的比较,筛选不同的检测方法,最终选择TOC法进行硫酸依替米星氯化钠注射液清洁验证残留物的检测。对方法检测限、线性、精密度、准确度进行验证,并进行三批产品清洁验证样品检测。结果:总有机碳分析方法验证的检测限、线性、精密度、准确度均符合要求,在实际应用中方便快捷。三批清洁验证样品的检测结果低于规定的允许残留值。结论:总有机碳(TOC)检测适用于硫酸依替米星氯化钠注射液的清洁验证检测。

Objective: Investigate the applicability of total organic carbon (TOC) in Etimicin Sulfate and Sodium Chloride Injection cleaning validation.Method : By comparing the sensitivity and maneuverability of the detection methods, the different detection methods are screened. TOC method is selected to detect the Etimicin Sulfate and Sodium Chloride Injection cleaning residue. The detection limits, linearity, precision and accuracy of the method were verified, and three batch products were tested for cleaning verification samples. Results: The detection limits, linearity, precision and accuracy of the TOC method are all meet the requirements, and convenient in practical application. The test results of the three batch of clean validation samples are lower than the permitted residual values. Conclusion: Total organic carbon (TOC) analysis is suitable for Etimicin Sulfate and Sodium Chloride Injection's cleaning validation test.