Which types of stability testing are considered the main ones?

The main types of stability testing are accelerated and long-term stability testing because they are fundamental to establishing the shelf life and storage conditions for pharmaceutical products.

Accelerated stability testing is designed to predict the shelf life of a drug product by exposing it to higher-than-normal temperatures and humidity. This method helps to speed up the degradation processes that happen over time, allowing manufacturers to get an estimate of the product's stability within a much shorter timeframe. It focuses on observing how the product behaves under stress conditions to understand its stability profile.

Long-term stability testing, on the other hand, involves storing the product under recommended storage conditions for an extended period to assess how it maintains its quality and efficacy over time. This type of testing provides insights into the drug's actual shelf life and ensures that it remains safe and effective for patients throughout its intended use.

Together, these two types of testing form the backbone of stability studies, as they help manufacturers meet regulatory requirements and ensure that their products are safe and effective during their shelf life.