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Long-term, or real-time, stability testing programs subject products to recommended storage conditions and typically use a longer observation period for degradation to establish the product’s shelf-life. This testing method differs from accelerated shelf-life testing, which instead exposes products to elevated storage environments. The drug product is monitored under specific storage conditions until it no longer exhibits the expected quality standards. A long-term stability study usually lasts a minimum of 12 months, but may extend beyond that.
Long-term stability testing is essential to determine the shelf life and storage duration of products under their expected environmental conditions. This provides manufacturers and consumers with insight into when products will stop working as intended. Even if the stability properties of an API are considered to be fully understood, long-term stability testing may be used if packaging changes or product composition is changed.
Accelerated stability studies
In an accelerated stability study, pharmaceutical products are subjected to exaggerated stress conditions for six months. Elevated conditions are meant to accelerate the rate of product decomposition. Conducting an accelerated stability study allows pharmaceutical professionals to make decisions about the product’s shelf life. For example, if a product is stable at 40℃/75% RH for an accelerated study period of six months, it can be assigned a shelf life of 24 months. A successful accelerated stability study can speed up the process of getting a drug to market, but full approval must be supported by “real-time” data.
Intermediate Stability Studies
Intermediate stability studies are not always required, but may be used if a significant change in product occurs at any time during accelerated testing. Intermediate studies are designed to moderately increase the rate of chemical degradation or physical transformation of a drug substance or drug product.
