Medical
Drug Stability Test
The effectiveness and safety of drugs have attracted much attention, and it is also a livelihood issue that the country and government attach great importance to. The stability of drugs will affect the efficacy and safety. In order to ensure the quality of drugs and storage containers, stability tests should be performed to determine their effective time and storage state. Stability test mainly studies whether the quality of drugs is affected by environmental factors such as temperature, humidity and light will change over time and the correlation, and studies the degradation curve of drugs, according to which the effective period is presumed to ensure the effectiveness and safety of drugs when used. This article collects the standard information and test methods required for stability tests for customers' reference.
No.1 Drug stability test criteria
Storage conditions of drugs:
Storage Conditions**Note 2 | |
Long-term test | 25℃±2℃/60%±5%RH or 30℃±2℃/65%±5% RH |
Accelerated test | 40℃±2℃ / 75%±5%RH |
Intermediate test*note 2 | 30℃±2℃ / 65%±5%RH |
Note 1: If the long-term test condition has been set at 30℃±2℃/65% ±5%RH, there is no intermediate test, if the long-term storage condition is 25℃±2℃/ 60% ±5%RH and there is a significant change in the accelerated test, intermediate test should be added. And should be assessed against the criteria of "significant change".
Note 2: Sealed impervious containers such as glass ampoules can be exempted from humidity conditions. Unless otherwise determined, all tests shall be carried out in accordance with the stability test plan in the interim test.
The accelerated test data should be available for six months. The minimum duration of the stability test is 12 months for the intermediate test and the long-term test.
Store in refrigerator:
Storage Conditions | |
Long-term test | 5℃±3℃ |
Accelerated test | 25℃±2℃ / 60%±5%RH |
Store in freezer:
Storage Conditions | |
Long-term test | -20℃±5℃ |
Accelerated test | 5℃±3℃ |
For preparations that may suffer from solvent loss, such as water or solvents, if packaged in a semi-permeable container, the stability evaluation should be conducted at low relative humidity for a long term test or an intermediate test for 12 months and an accelerated test for 6 months to demonstrate that the drug in a semi-permeable container can withstand low relative humidity.
Aqueous or solvent:
Storage Conditions | |
Long-term test | 25℃±2℃/40%±5%RH or 30℃±2℃/35%±5% RH |
Accelerated test | 40℃±2℃ no more than 25%RH |
Intermediate test*note 1 | 30℃±2℃ / 35%RH±5%RH |
Note 1: If the long-term test condition is 30℃±2℃ / 35%±5%RH, there is no intermediate test. | |
The relative water loss rate at a constant temperature of 40℃ is calculated in the following table:
Replacement relative humidity (A) | Compare relative humidity (R) | Water loss rate ratio |
60%RH | 25%RH | 1.9 |
60%RH | 40%RH | 1.5 |
65%RH | 35%RH | 1.9 |
75%RH | 25%RH | 3 |
Description: For aqueous drugs placed in semi-permeable containers, the water loss rate at 25%RH is three times that of 75%RH. | ||
No.2 Drug stability solutions
Common drug stability test criteria
(Source: Food and Drug Administration, Ministry of Health and Welfare)
Item | Storage Conditions |
Long-term test | 25°C /60% RH |
Accelerated test | 40°C /75%RH |
Intermediate test | 30°C/65%RH |
(1) Wide applicable temperature test
Item | Storage Conditions |
Long-term test | Low or sub-zero temperature conditions |
Accelerated test | Normal humidity or low temperature conditions |
(2) Test facility
1. Constant Temperature and Humidity Test Chamber
2. Drug stability Test Chamber
