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Long-term storage stability testing is a critical process used to assess how a product’s quality, safety, and efficacy change over an extended period when stored under recommended conditions. This testing helps determine the product’s shelf life and supports the establishment of a scientifically justified expiration date.
By simulating real-time storage environments—such as controlled temperature, humidity, and light exposure—this testing evaluates changes in physical appearance, chemical composition, potency, and microbial stability over time. It ensures that the product remains effective and safe for use throughout its intended lifespan.
Long-term stability data are essential for regulatory submissions, product labeling, and ensuring consistent performance during distribution and storage. This testing is particularly important for pharmaceuticals, medical devices, and biologics, where degradation could affect therapeutic outcomes or patient safety.
