Stabilizotóvizsgálatok

Stabilizotóvizsgálatok, commonly translated as stability testing, refers to a series of analytical procedures performed to assess the stability of a product or substance over time under various environmental conditions. The primary goal is to determine how the quality of a product varies as a function of time under the influence of such factors as temperature, humidity, and light. This information is crucial for establishing a shelf life and recommended storage conditions.

These tests are widely applied in the pharmaceutical, food, cosmetic, and chemical industries. For pharmaceuticals, stability testing is a regulatory requirement to ensure the safety and efficacy of drugs throughout their intended use period. It helps identify degradation products and monitor the rate at which they form. In the food industry, it ensures that products remain safe and retain their nutritional value and sensory characteristics.

The testing typically involves storing samples under controlled conditions, which can include accelerated conditions (higher temperature and humidity to speed up degradation) and real-time conditions (actual storage conditions). Samples are then analyzed at predetermined intervals using validated analytical methods. These methods may include techniques such as High-Performance Liquid Chromatography (HPLC) to measure active ingredient content and detect impurities, dissolution testing for solid dosage forms, and physical tests like appearance, pH, and viscosity. The data generated from stabilizotóvizsgálatok allows manufacturers to predict the shelf life and develop appropriate packaging to protect the product from degradation.