Technical Requirements for Low Temperature Cycle and Freeze-thaw Stability Test of Injection
Objective:The concept of low temperature cycle and freeze-thaw stability test of injection dosage form is introduced in this paper,and the importance of low temperature cycle and freeze-thaw stability test for injections is discussed.Methods:Through comparing the requirements of NMPA,ICH,and FDA guidance,this paper summarizes the low-temperature cycling and freeze-thaw stability testing of drugs and provides an overview of the technical requirements of each element.Results:By using Edaravone injection as an example,the specific content of the technical requirements for low-temperature cycling and freeze-thaw stability testing was confirmed.Conclusion:Based on the stability guidelines of NMPA,ICH,and FDA,and the requirements of handling a pharmaceutical product under various conditions such as extre33me and rapid temperature changes which we may encounter in a real world,we would design a reasonable protocols for a complete,accurate and comprehensive testing of low-temperature cycling and freeze-thaw stability.
low temperature cyclefreeze-thawstability testinjectiontechnical requirements
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