Paration and Quality Investigation of Desmopressin Acetate for Injection
Objective:To establish a suitable freeze-drying process for bortezomib injection.Methods:Vacuum freeze-drying process was evaluated,including conditions such as medicinal liquid volume,pre-freezing temperature,sublimation drying temperature,desorption drying temperature,etc.Results:The optimal conditions were 0.8 mL medicinal liquid per bottle,pre-freezing temperature-40 ℃.Under vacuum condition,sublimation drying temperature was-40～-25 ℃ and the desorption drying temperature was 35 ℃.Conclusion:The bortezomib for injection prepared by this process has been verified to be suitable for mass production,and the product quality meets national standards and regulations.
bortezomib injectionvacuum freeze-dryingprepare process
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