A method used in product development determines how long a product remains acceptable under specific storage conditions. This process involves subjecting a product to exaggerated environmental factors such as high temperature and humidity to simulate the effects of long-term storage over a shorter period. For example, placing a medication at 40C and 75% relative humidity for six months may provide data equivalent to two years of storage at room temperature.
This methodology offers significant advantages. It expedites the product development timeline, enabling manufacturers to bring products to market faster. Furthermore, it helps identify potential degradation issues early, facilitating formulation adjustments or packaging modifications to improve product longevity. Historically, this type of evaluation was time-consuming, requiring lengthy observation periods under normal conditions. The advent of predictive modeling and specialized instrumentation has made the process more efficient and accurate.
