色谱类分析仪器性能确认用标准物质的筛选  

Screening on the Reference Material for Performance Qualifi cation of Chromatographic Analytical Instruments

作　　者：初侨[1] 席兴军[1] 兰韬[1] 唐飞 王鹤妍 董跟来 张晓芳[1] Chu Qiao;Xi Xingjun;Lan Tao;Tang Fei;Wang Heyan;Dong Genlai;Zhan Xiaofang(China National Institute of Standardization, Beijing　100191, China;China National Institute of Standard Technology, Beijing 100029, China)

机构地区：[1]中国标准化研究院,北京100191 [2]中标标准技术研究所,北京100029

出　　处：《化学分析计量》2017年第3期101-105,共5页Chemical Analysis And Meterage

基　　金：中央基本科研业务费专项经费(562016Y–4687;562016Y–4492;562017Y–5284);质检公益性行业科研专项项目(201510048–4)

摘　　要：分析仪器验证是制药、食品、环境等多个行业实验室质量管理的重点,为解决我国色谱类分析仪器验证评价体系中缺乏统一标准物质的问题,提出了筛选性能确认行业推荐用标准物质的原则。通过分析不同行业色谱类分析仪器标准物质使用情况和国家标准及有证标准物质的发布现状,以筛选原则为指导,筛选出93种高效液相色谱性能确认用标准物质。为保证分析仪器的稳定性和可靠性提供了标准依据。Analytical instrument was the focus of quality management in the pharmaceutical,food,environment and other industries laboratory,in order to solve the lack of unified reference material in the validation and evaluation system of chromatographic analytical instrument,the principle of screening reference material for performance qualification was put forward.Based on the principle of screening,93kinds of reference materials for high performance liquid chromatography performance qualification were screened out after investigating the case of reference materials and national standard.The result provide a reference basis to guarantee the stability and reliability of the analytical instruments.

关 键 词：色谱类分析仪器 标准物质 筛选 性能确认 

分 类 号：O657.7[理学—分析化学]