Quality Control and Stability of Scopolamine Hydrobromide
Abstract：Objective: To determine the Scopolamine Hydrobromide drug storage conditions and period.Method:The stability of Scopolamine Hydrobromide was investigated through acid destruction,alkaline destruction,oxidative destruction,light destruction,high-temperature destruction, accelerated test and long-term test.Change trends of main content and impurity content of scopolamine hydrobromide were determined by HPLC.Result:In stress stability test,Scopolamine hydrobromide was stable at high-temperature and oxidative destruction test. The API was sensitive to light and was unstable under conditions of acid and alkaline destruction. Tropic acid increased as main degradation product in these tests. No obviously change occurred in the accelerated test(40℃,75%Rh for six months) and long-term test(25℃,60% Rh for 2 years).Conclusion:Scopolamine Hydrobromide should storage in a container protected from light. The API is stable in two years under room temperature.
Keywords：Scopolamine HydrobromideStability testsRelated compounds
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 23-25 )