High-low Temperature Test Chambers are commonly used in the pharmaceutical industry for drug stability research and storage condition optimization. The high-low Temperature Test Chamber can test the thermal stability, cold stability and damp heat stability of drugs to evaluate the stability of drugs under different temperature and humidity conditions and determine their most suitable storage conditions.
application background
The reason why drugs need to be tested for high-low temperature resistance is because drugs will face different temperature environments during transportation, storage, use, etc. If the drug cannot withstand the high-low temperature environment, the quality of the drug will be affected, thereby reducing the efficacy and even create safety hazards. Through the high-low temperature resistance test, the stability and safety of drugs at different temperatures can be evaluated, their changes at different temperatures can be understood, and scientific basis can be provided for the quality control and guarantee of drugs.
experiment procedure
Determine the test samples, distribute the medicines into appropriate containers as required, seal them well and clearly mark them.
Place the sample in the high-low Temperature Test Chamber, and set the corresponding temperature and humidity conditions. Under normal circumstances, the test temperature is 25°C, 30°C, 40°C, 50°C, 60°C, 70°C and other different temperatures, and the humidity can be set to 30%, 50%, 60%, 75% according to requirements % and other humidity.
During the test, regularly check the appearance and properties of the drug samples, such as color, smell, shape, content, etc. The stability of drugs can be evaluated by means of effective liquid chromatography, infrared spectroscopy, and ultraviolet spectroscopy.
Based on the experimental results, determine the optimum storage conditions for the drug.
