What is the primary objective of stability testing in pharmaceutical development?

The primary objective of stability testing in pharmaceutical development is to determine the shelf life and proper storage conditions of a pharmaceutical product. This process involves assessing how a drug product maintains its quality, safety, and efficacy over time under various environmental conditions, such as temperature, humidity, and light exposure.

By conducting stability tests, pharmaceutical developers can establish expiration dates and recommend appropriate storage conditions that ensure the product remains effective for the duration of its shelf life. This is critical not only for compliance with regulatory requirements but also for ensuring that patients receive medications that are safe and effective throughout their intended use. Stability testing ultimately supports the product's labeling and helps ensure that it meets the quality standards necessary for market approval.