Note: In order to ensure the quality of the drug, a stability test is required to estimate its effective time and storage state. The stability test mainly studies whether the quality of the drug is affected by environmental factors such as temperature, humidity and light, and it will change with time and relevance. The drug degradation curve was developed to estimate the effectiveness and safety of the drug during use.
Storage conditions for medicines:
Storage conditions ** Note 2 Long-term test 25 ° C ± 2 ° C / 60% ± 5% RH or 30 ° C ± 2 ° C / 65% ± 5% RH test accelerated test 40 ° C ± 2 ° C / 75% ± 5% RH intermediate test *Note 1 30 ° C ± 2 ° C / 65% ± 5% RH Note 1: If the conditions of the long-term test have been set to 30 °C ± 2 ° C / 65% ± 5% RH, there is no intermediate test, if the long-term storage conditions are carried out at 25 ° C ± 2 ° C / 60% ± 5% RH In the case of a significant change in the accelerated test 12, an intermediate test should be added. It should be evaluated against the criteria of “significant changeâ€.
Note 2: Closed impervious containers such as glass ampoules can avoid humidity conditions. Unless otherwise determined, in the intermediate test, all inspection items shall be executed in accordance with the stability test plan. The accelerated test data requires six months, the intermediate test and the long-term test of the stability test, and the minimum cover time is twelve months.
Note 2: Closed impervious containers such as glass ampoules can avoid humidity conditions. Unless otherwise determined, in the intermediate test, all inspection items shall be executed in accordance with the stability test plan. The accelerated test data requires six months, the intermediate test and the long-term test of the stability test, and the minimum cover time is twelve months.
Store in the refrigerator:
Storage conditions Long-term test 5°C±3°C Accelerated test 25°C±2°C / 60%±5%RH Stored in the freezer:
Storage conditions Long-term test -20°C±5°C Accelerated test 5°C±3°C A formulation containing water or solvent that may cause solvent loss. If it is packaged in a semi-permeable container, the stability evaluation should be carried out at a low relative humidity for a long-term test or intermediate test for 12 months, and the accelerated test for 6 months to prove A drug placed in a semi-permeable container that withstands low relative humidity.
Storage conditions Long-term test Perform a long-term test at 25 °C ± 2 °C / 40% ± 5% RH or 30 °C ± 2 °C / 35% ± 5% RH. Accelerated test 40 °C ± 2 °C no more than 25% RH Intermediate test * Note a 30 ° C ± 2 ° C / 35% RH ± 5% RH Note 1: If the long-term test conditions are 30 ° C ± 2 ° C / 35% ± 5% In the case of RH, there is no intermediate test. The calculation of the relative water loss rate at a fixed temperature of 40 ° C is as follows:
Alternative Relative Humidity (A) Control Relative Humidity (R) Water Loss Rate Ratio ([1-R]/[1-A]) 60%RH 25%RH 1.9 60%RH 40%RH 1.5 65%RH 35%RH 1.9 75% RH 25% RH 3.0 Description: The water-containing drug placed in a semi-permeable container has a water loss rate of three times that of 75% RH at 25% RH.
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