The stability study on pigmentum Fengdima
SUN Yan
XU Feng-hua
WANG Huan-huan
Abstract：Objective: To investigate the stability of pigmentum Fengdima and provide reference for its storage and utilization. Methods:A multiple gradient HPLC method was used to simultaneously determine the content of tetracaine hydrochloride and ephedrine hydrochloride. The appearance, pH and contents of tetracaine hydrochloride and ephedrine hydrochloride were investigated by inlfuence factors test and long-term test, according to the guidance for stability test of preparation stated in Chinese Pharmacopeia (2010 edition). Results:The results of inlfuence factors test showed that the contents of tetracaine hydrochloride and ephedrine hydrochloride decreased under 60℃and high humidity conditions. Long-term test results showed that no obvious change was observed in quality indexes. Conclusion:Pigmentum Fengdima was a relatively stable preparation, and its shelf-life was tentatively set up as one year.
Keywords：Pigmentum FengdimaStabilityInlfuence factorLong-term test
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 209-211 )