Factors considered for Stability Testing
Stability testing is a process utilized for the evaluation and validation of the quality of pharmaceutical ingredients and drugs. Stability testing is also performed for the evaluation of different processes in pharmaceutical manufacturing, such as drying, granulation, and pulverization. Stability testing has been performed on batches of drug substances, excipients, and finished products to assess their shelf-life.
This ensures that the finished products are as safe and effective as they can be. Stability storage and testing are critical components of a drug development process. They help gather data and inform decisions regarding the next phase of the development.
Factors such as safety, quality, and efficacy are also taken into account when conducting stability studies. Many companies that develop drugs have the capability to identify and trend the shelf life of their products by exposing samples to varying conditions. In-use stability testing is also performed for multi-dose products. This test involves taking into account the various factors that affect the use of a given product in practice. The goal of in-use stability testing is to simulate the use of a given product in practice.
Various factors such as the physical properties of the drug, its microbiological causes, and the chemical composition of the compound are studied to identify potential drug degradability. Knowing the various factors that could affect a finished product or an API is very important in conducting stability tests. These studies help scientists determine the optimal way to store and transport a finished product. They also help determine the safety and efficacy of a given product.
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