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Stability analysis is an area of great interest in preformulation studies. It is a complex set of procedures performed on candidate drug molecules or dosage forms for their final immediate packaging intended for marketing and, where appropriate, novel formulation excipients. By investigating the internal stability of candidate drug molecules, useful information that can improve the integrity of drug products, as well as, prevent changes in its physical properties, chemical properties and pharmacological effects.
Preformulation stability analysis includes solid-state stability analysis, solution-state stability analysis and drug-excipient compatibility studies. The key to a good stability analysis is to select concentrations for analysis that allow the detection of degradation product peaks that are at least 0.1% of the parent peak. The stability design and type of testing used will depend on the stage of the development process and the nature of the drug and product under test.
Stability testing is a process by which pharmaceutical manufacturers observe their products under specified environmental conditions for a predetermined period of time to determine if there is any change in the quality of the Active Pharmaceutical Ingredient (API) or Final Product (FP). When manufacturing pharmaceuticals and other FDA-regulated products, there are many factors that must be tested before the product is approved and released to the public for use. Pharmaceutical manufacturers must monitor the effects of various environmental factors such as light, temperature and humidity on their products.
Stability testing is important for determining factors such as a product’s shelf life, optimal storage conditions, retesting periods, and ensuring its overall quality for consumers. During a stability test, pharmaceutical manufacturers monitor their product for any changes in the physical, chemical, biological, and microbiological makeup of the substance. All of these ingredients can affect the product’s safety and effectiveness for the consumer, so extensive testing is essential before placing a drug or cosmetic on the market.
