Accelerated Stability Study; Different Guidelines

The accelerated Stability Study method is developed to predict the stability and shelf life of products under normal or recommended storage conditions by different guidelines. These recommended methods are used to carry out a study of products under different accelerated conditions by using temperature, moisture, and light.

As can say an accelerated stability study is used to determine the shelf life and potential degradation of a drug product under different environmental conditions. Accelerated stability studies are typically conducted by storing the drug product at higher temperatures and/or humidities. then, would be undergone under normal storage conditions. The drug product is then analyzed at predetermined intervals to examine any changes in its physical, chemical, and/or biological properties. The results of the accelerated stability study are used to establish expiration dates and storage conditions for that product.

It is important to note that the results of an accelerated stability study may not accurately predict the long-term stability of a drug product under real-world storage conditions. Therefore, it is typically recommended to confirm the results of an accelerated stability study with a separate long-term stability study under actual storage conditions.

ICH and WHO guidelines on stability studies

The International Council for Harmonisation (ICH) and WHO are both international organizations that have designed their own guidelines and recommendations for the development, registration, and regulatory approval of pharmaceutical products. Both organizations have published guidelines on stability studies to provide guidance on the conduct and evaluation of stability studies for pharmaceutical products.

The ICH has published a number of guidelines on stability studies, including the following:

The WHO has also published guidelines on stability studies, including the following:

The Different Climate Zone

Understand the different climate zones and their condition to store a drug product for an Accelerated Stability Study.

Country Zone

Understand the different Zones that fall under respective countries.

The objective of the Accelerated Stability Study

• The main objective of an accelerated stability study is to know the impact of environmental conditions (such as temperature, humidity, and light) on a product’s stability. The study is carried out by putting the product under extreme conditions that will probably accelerate the rate of degradation or change in the product and then comparing the results to those obtained when the product was tested under regular storage environments.
• The purpose of an accelerated stability study is to estimate the shelf life of a product, which is the length of time that a product can be stored and still meet its intended quality, purity, and potency standards. This information is essential to maintaining the product’s safety and effectiveness, as well as for planning and implementing proper storage, handling, and distribution methods.
• Accelerated stability studies are frequently carried out with real-time stability studies, which involve storing the product under normal conditions and testing it on a regular basis to measure its stability over time. Then, Results obtained from both types of studies have been used to create a stability-indicating assay.

Related: Accelerated stability testing (study) Important Questions

Time/Storage Condition for a Stability Study

Below learn about Different types of stability study and their storage candition.

Prediction of self -Life equation

Arrhenius’s equation explains the effect of temperature on the rate of reaction. according to Arrhenius equation for every 10°C rise, the speed of reaction is about 2 to 3 times.

K= Ae^-Ea/RT

Log K= LogA-Ea/2.303RT

Steps involved in Accelerated stability study/Testing

• The preparation is stored at different elevated temperatures likes (40, 50, 60, and 70°C)
• the concentration of a reactant at each elevated temperature is also determined.
• Samples are withdrawn at different time intervals
• The rate of reaction is determined by plotting the concentration against time and a linear relationship is determined.
• The straight line in a graph permits the estimation of the k value from the slope, from the slope of the line reaction rate constant k for degradation at each elevation temperature is calculated.
• The reaction rate constant k for degradation of room temperature that is 25°C is determined.
• The k value obtained for 25°C is substituted in the already determined order of reaction and an estimate is obtained for the self-life of the product.

Limitation of accelerated stability analysis:

• Stability prediction based on the Arrhenius equation is valid only when the energy of activation for thermal decomposition lies between 10 to 30 kcal/mole
• This method is not used in the case of complex reactions because the Arrhenius equation consists of only one rate constant.
• This method is not applicable if degradation is due to freezing, microbial contamination, or excess agitation.
• A product that loses its physical integrity at elevated temperatures is not suitable for this method.
• It is not valid when the order changes at a higher temperature.