甲钴胺标准物质原料的引湿性研究  

Study on Hygroscopicity of Raw Material for Mecobalamin Reference Substance

作　　者：刘毅[1] 郭贤辉 覃玲[1] 严菁[1] 陈华[1] Liu Yi;Guo Xianhui;Qin Ling;Yan Jing;Chen Hua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2023年第8期961-965,共5页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院化学药品检定所重点实验室学科建设项目(编号2023HYZX25)。

摘　　要：目的:探讨强引湿性标准物质甲钴胺研发过程中需要注意的应用性问题,为解决相似标准物质研发难题提供思路和借鉴。方法:采用动态水分吸附分析法(DVS)开展甲钴胺标准物质原料的引湿性研究,DVS设定温度为25℃,载气N2流速200 mL·min^(-1)。结果:推荐选用水分含量5%的标准物质原料,并建议在环境湿度RH40%~RH50%的质控实验室快速完成称量工作。结论:本研究为确定合适水分含量的标准物质原料以及合理的应用条件等提供了数据支持和参考依据。Objective:To study the application issues that need to be paid attention to in the research and development of strong hygroscopic mecobalamin reference substance,and to provide ideas and information for solving the similar research and development difficulties.Methods:Dynamic vapor absorption analysis(DVS)was applied to study on hygroscopicity of raw material for mecobalamin reference substance.During the analysis with DVS,the temperature was set at 25 ℃,and the carrier gas fiow rate of N2 was 200 mL·min~(-1).Results:Raw material of mecobalamin reference substance with 5% water content was recommended,and it was suggested to quickly complete the weighing work in the quality control laboratory with the ambient humidity of RH40%-RH50%.Conclusion:The study provided data support and reference basis for the determination of raw material of mecobalamin reference substance with appropriate water content and reasonable application conditions.

关 键 词：甲钴胺 引湿性 动态水分吸附 标准物质 

分 类 号：R917[医药卫生—药物分析学]