Säilyvyystestien

Säilyvyystestien refers to stability testing conducted on products, particularly pharmaceuticals, food items, and cosmetics, to determine their shelf life. These tests assess how a product's quality attributes change over time under specific environmental conditions, such as temperature, humidity, and light. The primary goal is to establish a period during which the product remains safe, effective, and meets its quality specifications.

The process typically involves storing samples of the product under various controlled conditions that simulate real-world storage and potential stress factors. Samples are then analyzed at predetermined intervals to monitor key parameters. For pharmaceuticals, these parameters might include potency of the active ingredient, dissolution rate, and the presence of degradation products. In the food industry, tests could focus on nutrient content, texture, color, flavor, and microbial growth. For cosmetics, stability tests might evaluate changes in viscosity, pH, color, odor, and the separation of ingredients.

Accelerated stability testing is a common method where products are exposed to more extreme conditions (e.g., higher temperature and humidity) to predict long-term stability more quickly. Real-time stability testing, on the other hand, involves storing samples under recommended conditions for the entire proposed shelf life. The data gathered from these tests is crucial for regulatory submissions, product labeling (such as expiration dates), and ensuring consumer safety and product efficacy throughout its intended lifespan.