FDA Stability Guidelines

Stability test guidelines established by the Food and Drug Administration help to govern drug-testing conditions. The FDA provides these guidelines as recommendations to researchers to test new and experimental drugs under equal conditions to other established drugs.

Considerations

• When performing a stability test, a researcher must define the active ingredient in the drug and the potency of the substance, and explain how he prepared the drug using the active ingredient. He must also include information about the chemical and physical properties of the active ingredient as well as any other substances he has added.

Storage

• A researcher controls the storage environment of her drugs after study, including the storage container and expiration date, as well as transport conditions when necessary. She must also consider at temperature she wants to store the drug: room temperature, a higher temperature or freezing. She should store her drugs for at least the shorter end of a product's shelf life or its recall specification limit.

Time Frame

• Stability tests should occur over a specified period. For example, a researcher must consider whether he will use a regular time frame, such as a year, or perform "stress testing" in which he runs the same test over an accelerated period, such as six months. Stress testing helps identify product degradation and therefore the stability of a drug.