制药用水中总有机碳测定仪的系统适用性试验研究

Study on System Suitability Test of the Total Organic Carbon Analyser in Pharmaceutical Waters

目的:测试TOC-VCSH型总有机碳分析仪是否符合系统适用性试验要求。方法:采用高温氧化法,分别测定易氧化物与难氧化物的仪器响应值,计算响应效率,以考察仪器的氧化能力和系统的适用性。结论:经测定,TOC -VCSH型总有机碳分析仪符合系统适用性试验要求,可以用于制药用水中总有机碳含量的测定。

Objective： To test wether the total organic carbon analyser（TOC- VCSH ）matches the request of system suitability or not. Methods： Using the method of heating oxidization w determine the response of easy- to-oxidize matter and difficult-to-oxidize matter respectively, then, We calculate the response efficiency in order W examine the System Suitability. Results： the response efficiency is 90.4 %. Conclusion： the total organic carbon analyser（TOC-VCSH meets the request of system suitability, it can used for the measurement of the content of total organic carbon in pharmaceutical waters.