Thoughts on determination method of the related substances in halometasone/triclosan cream
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.
NETL
NSTL
万方数据
