盐酸金刚乙胺纯度标准物质研制  

Preparation of Rimantadine Hydrochloride Purity Certified Reference Material

作　　者：李付凯 王敏[1] 周剑[1] 杨梦瑞[1] 王彤彤[1] 李亮 LI Fukai;WANG Min;ZHOU Jian;YANG Mengrui;WANG Tongtong;LI Liang(Institute of Quality Standard and Testing Technology for Agro-products,Chinese Academy of Agricultural Sciences,Beijing 100081,China)

机构地区：[1]中国农业科学院农业质量标准与检测技术研究所,北京100081

出　　处：《计量科学与技术》2023年第10期37-45,共9页Metrology Science and Technology

基　　金：国家重点研发计划项目(2022YFF0607904);中国农业科学院所级基本科研业务费项目(1610072023014、1610072023101);中国农业科学院科技创新工程(CAAS-ASTIP-2023-IQSTAP)。

摘　　要：采用“质量平衡法”和“定量核磁法”两种独立方法研制了盐酸金刚乙胺纯度标准物质(GBW10262)。对标准物质研制过程中的关键因素,如均匀性、稳定性、定值和不确定度等进行了系统研究。两种方法测得的盐酸金刚乙胺纯度值为99.7%±0.3%(k=2)。所研制的盐酸金刚乙胺标准物质均匀性良好,长期稳定性可保持20个月,并且在7天内保持稳定(50℃)。同时,对定值、稳定性、均匀性等不确定度来源进行了评估。所研制的盐酸金刚乙胺有证标准物质将为仪器检定、方法验证、质量安全风险监测等实施提供支撑。The development of a rimantadine hydrochloride purity certified reference material(CRM)(GBW 10262)was carried out using two independent methods:the mass balance(MB)method and quantitative nuclear magnetic resonance(qNMR)spectroscopy.Critical aspects of the CRM development process,including homogeneity,stability,calibration,and uncertainty,were systematically investigated.The purity of rimantadine hydrochloride CRM,as determined by both methods,was found to be 99.7%±0.3%(k=2).The CRM demonstrated excellent homogeneity,maintaining long-term stability for 20 months,and short-term stability for seven days at 50℃.The study also involved a thorough assessment of uncertainty sources,including characterization,stability,and homogeneity.The rimantadine hydrochloride CRM will support activities such as instrument calibration,method validation,and quality and safety risk monitoring.

关 键 词：计量学 金刚乙胺 均匀性 纯度 有证标准物质 不确定度评估 质量平衡法 定量核磁法 

分 类 号：TB99[一般工业技术—计量学]