Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. This study helps to determine the shelf-life of that product. Storage Condition Recommendation: Different products require different storage conditions.
Stability Testing is the process for determining, through storage at defined conditions and testing at specific intervals, how long a drug substance or product remains safe and effective at particular storage conditions.
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.
Stability Data Standard is a Health Level Seven (HL7) standard to facilitate the processing and review of stability data. To that end, the Agency is evaluating the use of electronic data exchange standards for receiving stability and other quality (chemistry, manufacturing and controls) data in eCTD submissions.
Stability Testing is a type of Software Testing to check the quality and behavior of the software in different environmental parameters. It is defined as the ability of the product to continue to function over time without failure.
The stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests.
- Stable Equilibrium.
- Unstable Equilibrium.
- Metastable Equilibrium.
Stability testing is an important part of the drug development and approval process, determining the safety and integrity of the drug and also its shelf life and storage conditions.
7 Steps for Stability Testing
- Step 1: Batch Production.
- Step 2: Product Container Filling.
- Step 3: Initial Test (Time Point Zero).
- Step 4: Product Storage.
- Step 5: Product Evaluation.
- Step 6: Determine Stability.
- Step 7: Conclusion Report.
Formal stability study should consist of accelerated and long term stability testing on at least two primary production batches for stable drug products and in case of the susceptible drug products at least three primary production batches should be considered.
A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in the chemical, physical or microbiological properties of the drug substance and drug products are specific so that the content of active ingredients and degradation products can be
“Inâ€use stability studies are studies conducted to demonstrate that under normal conditions of use and intended time period of use, the product quality is maintained as it relates to patient safety and efficacyâ€.
An example of stable is a product that has a steady and unchanging price.
real-time (long-term) stability studies Experiments on the physical, chemical, biological, biopharmaceutical and microbiological characteristics of a drug, during and beyond the expected shelf-life and storage periods of samples under the storage conditions expected in the intended market.
Place the product at -10oC for 24 hours and place it at room temperature (25oC) for 24 hours. This completes one cycle. If the product passes three cycles then you can have a good degree of confidence in the stability of the product. An even more rigorous test is a -10oC to 45oC five-cycle test.
Throughout the world, there are 5 different ICH Stability Zones:
| Climatic Zone | Type of Climate | Long term Stability Testing Recommended Conditions |
|---|
| Zone I | Temperate | 21°C/45%RH |
| Zone II | Mediterranean/Subtropical | 25°C/60%RH |
| Zone III | Hot, Dry | 30°C/35%RH |
| Zone IVa | Hot Humid/ Tropical | 30°C/65%RH |
These stability studies zones are created due to the difference in temperature and humidity in different parts of the world. These zones have different ICH stability conditions for pharmaceutical products. Following are ICH stability conditions for these zones.
Intact stability
- Lightship or Light Displacement.
- Full load departure or full displacement.
- Standard condition.
- Light arrival.
