Objective: To establish the determination methods for muscone in Jiuwei Fangwensan and to study the stability of the formulation. Method: Firstly

the HPLC-MS method for muscone in Jiuwei Fangwensan was established. In addition

the effect of temperature and sealed condition on the stability of Jiuwei Fangwensan was evaluated. Result: Muscone showed a good linear relationship in the range of 0.2-20 mg·L-1(r=0.999 9).Precision

recovery rate

stability

repeatability were in line with the experimental requirements. Stability experiment showed that the loss rate of muscone in group without package was faster than group with package. Meanwhile

the loss rate of muscone in 35 ℃ and well package groups was faster than 4 ℃ and tightly package groups

respectively. Conclusion: The method is sensitive

accurate and could be used in the quality control and the stability study of Jiuwei Fangwensan. Muscone in the formulation is basically stable at 4 ℃ and tightly packaged condition.