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.

What is meant by stability testing?

Stability testing is the statistical analysis of how long a pharmaceutical product can be stored without any change in its original chemical composition. Pharmaceutical products when stored for long durations tend to undergo changes and release byproducts.

Why is stability testing done?

Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity.

What is real time stability testing?

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.

How do you know if an application is stable?

Performance Testing has many types and stability testing is one of them.Stress testing: It is a testing type which checks the robustness of the system beyond the system capacity.Spike testing: It is used to check the behavior of a system by increasing a load of a system instantly.More items •Aug 27, 2021