对卤米松/三氯生乳膏中有关物质检查方法的思考
Thoughts on determination method of the related substances in halometasone/triclosan cream
赵敬丹 1陈阳 1刘浩 1金薇 1乐健1
作者信息
- 1. 上海市食品药品检验研究院国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203
- 折叠
摘要
目的:通过卤米松/三氯生乳膏中最大单个未知杂质的结构推测,探讨进口注册标准的合理性.方法:采用国家食品药品监督管理局进口药品注册标准JX20080304中有关物质项下的色谱条件对样品进行杂质检查;采用USP三氯生项下的方法对样品中的二噁英类物质进行检查;采用LC-Q TOF/MS对样品中的最大单个未知杂质进行推测.结果:按照JX20080304测定,以卤米松计,样品中最大单个杂质(RRT 0.67)检出量为2.5％,超出标准规定的1.0％;结合三氯生对照品溶液的色谱保留行为,推测上述杂质可能来源于三氯生;结合杂质的MS信息,推测可能为三氯生的工艺杂质.结论:对于复方制剂,建议对主要相关成分中涉及的杂质分别进行控制,并根据安全性数据进行有效评估,以保证制剂产品质量的稳定性和临床用药的安全性.
Abstract
Objective:To analyze the structure of the maximum impurity in halometasone/triclosan cream and discuss the rationality of the current registered standard for imported drugs.Methods:The related substances in halometasone/triclosan were detected according to JX20080304,and dioxins were determined according to USP.Finally,the possible structures of the maximum impurity were characterized by LC-Q TOF/MS.Results:The results showed that the maximum unknown impurity(RRT 0.67),calculated according to halometasone was OOS(1.0％)at 2.5％.The peak was related to triclosan through comparing with the chromatography behavior of triclosan in reference substance solution.MS information indicted the process impurities of triclosan.Conclusion:For compound preparations,to ensure the stability and safety of the product,the impurities relevant to different components should be controlled separately at rational limit based on safety data.
关键词
卤米松/三氯生/杂质/二噁英/复方制剂/有关物质/安全性/质谱Key words
halometasone/triclosan/impurity/dioxins/compound preparation/related substances/safety/MS引用本文复制引用
出版年
2024
NETL
NSTL
万方数据