没食子酸丙酯纯度标准物质的研究
帅放文,王向峰,雷玉萍,肖江,曹荣,彭丽娟
湖南省药用辅料工程技术研究中心有限公司
Development of Propylgallate Certified Reference Material
帅放文,王向峰,雷玉萍,肖江,曹荣,彭丽娟
Hunan Engineering Research Center for Pharmaceutical Excipients Co., Ltd., Changsha 410331, China
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。
Abstract:Propylgallate certified 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 confirm evaluation of analysis method.
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
Keywords:propylgallate; reference material; high performance liquid chromatography; differential scanning calorimetry
本文引用格式:
帅放文,王向峰,雷玉萍,等.没食子酸丙酯纯度标准物质的研究[J].化学分析计量,2015,24(3):5-8.
SHUAI F W,WANG X F,LEI Y P,et al.Development of Propylgallate Certified Reference Material[J]. Chemical analysis and meterage,2015,24(3):5-8.
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