超级微波消解-电感耦合等离子体质谱法同时检测苯甲酸钠中12种元素杂质  

Simultaneous Determination of 12 Elemental Impurities in Sodium Benzoate by Ultra Microwave-assisted Digestion and Inductively Coupled Plasma Mass Spectrometry

作　　者：蔡立荣 梁晟 周斌 舒海平 谭跃 李昌亮 刘雁鸣 CAI Li-rong;LIANG Sheng;ZHOU Bin;SHU Hai-ping;TANG Yue;LI Chang-liang;LIU Yan-ming(Hunan Institute for Drug Control,NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Hunan Changsha 410001;Hunan Warrant Pharmaceutical Co.,Ltd.,Hunan Changsha 410006,China)

机构地区：[1]湖南省药品检验检测研究院,国家药监局药用辅料工程技术研究重点实验室,湖南长沙410001 [2]湖南华纳大药厂股份有限公司,湖南长沙410006

出　　处：《广州化工》2024年第17期57-59,66,共4页GuangZhou Chemical Industry

基　　金：湖南省自然科学基金科药联合基金资助项目(2023JJ60105、2023JJ60106)。

摘　　要：建立超级微波消解和电感耦合等离子体的方法并进行方法学验证。用所建方法对多个厂家的多批次苯甲酸钠中的1类、2A类、3类Li、Sb、Cu以及其他元素Fe和Zn共12种元素进行检测,以注射给药控制阈值进行风险评估。所建方法线性、检测限、定量限、准确度、精密度均符合法规要求,能够准确、快速地对苯甲酸钠中多种元素进行同时评估,实测数据显示12种元素均未超控制阈值,表明苯甲酸钠用于注射给药时元素杂质残留风险较低。A method using ultra microwave digestion and inductively coupled plasma(ICP)was established and validated.This method was applied to detect 12 elements,including Class 1,Class 2A,Class 3(Li,Sb,Cu)and other elements(Fe,Zn),in multiple batches of sodium benzoate from various manufacturers.The risk assessment was conducted using the control thresholds for parenteral administration.The results showed that the linearity,detection limit,quantitation limit,accuracy and precision of the established method all met regulatory requirements.The method was allowed for accurate and rapid simultaneous assessment of multiple elements in sodium benzoate.The actual data indicated that none of the 12 elements exceeded the control thresholds,suggesting that the risk of elemental impurities in sodium benzoate for parenteral administration was low.

关 键 词：药用辅料 苯甲酸钠 元素杂质 ICH Q3D 风险评估 

分 类 号：R917[医药卫生—药物分析学] R951[医药卫生—药学]