The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug
What does drug stability mean?
Drug preparations are considered stable if the active ingredient can maintain its strength at the level specified on the label for the maximum anticipated shelf-life (the time period from the date of manufacture until administration to the animal) under environmental conditions likely to be encountered in actual use.
How stability test is done?
As is well-known, stability testing essentially is an experiment in which a batch of formula is created and placed into different environmental conditions for a set period of time. These conditions vary in temperature and humidity, and are meant to simulate what happens to the product during its life cycle.
Why drug stability is very important?
Drug stability affects the safety and efficacy of the drug product; degradation impurities may cause a loss of efficacy and generate possible adverse effects. Therefore, achieving the chemical and physical stability of drugs is essential to ensure their quality and safety.
What is an example of price stability?
Policy is set to maintain a very low rate of inflation or deflation. For example, the European Central Bank (ECB) describes price stability as a year-on-year increase in the Harmonised Index of Consumer Prices (HICP) for the Euro area of below 2%.