摘要
研制了没食子酸丙酯纯度标准物质。依据国家《一级标准物质研制技术规范》,采用高效液相色谱(HPLC)法和差示扫描量热(DSC)法对没食子酸丙酯纯度标准物质进行联合定值,进行了相应的不确定度评定。研制的没食子酸丙酯纯度标准物质定值结果为(99.8±0.5)%(k=2,P=0.95)。该标准物质可用于相关药品生产及使用单位的质量控制和分析方法确认评价。
Propylgallate certifi ed reference material was developed. According to national Technical Norm of Primary Reference Material,the purity of propylgallate was determined by combined value assignment of high performance liquid chromatography(HPLC) and differential scanning calorimetry(DSC). The standard value and uncertainty of propylgallate CRM was(99.8±0.5)%(k=2,P=0.95). The purity of propylgallate could be used for pharmaceutical production,quality control and confi rm evaluation of analysis method.
出处
《化学分析计量》
CAS
2015年第3期5-8,共4页
Chemical Analysis And Meterage
关键词
没食子酸丙酯
纯度标准物质
高效液相色谱法
差示扫描量热法
propylgallate
reference material
high performance liquid chromatography
differential scanning calorimetry
