The shelf life is the period of time that a drug, if stored correctly, is expected to comply with the specification determined by stability studies on a number of batches of the product. Shelf life is used to determine the expiration date of each batch.
Real-time or long-term stability tests are tests on the physical, chemical, biological, biopharmaceutical and microbiological properties of a drug, under expected storage conditions on the shelves, during and after the expected shelf life and storage times. The results obtained are used to determine the shelf life, to verify the predicted shelf life and to determine the storage conditions.
Here, the term stability refers to the ability of a pharmaceutical product to maintain its chemical, physical, microbiological and biopharmaceutical properties within certain limits throughout its shelf life. Stability tests are a series of tests designed to obtain information about the stability of a pharmaceutical product to determine shelf life and expiry times under certain packaging and storage conditions.
Biocidal products should be stored at 25 degrees Celsius (plus/minus 2 degrees Celsius) for their specified shelf life and analyzed at 3, 6, 9, 12, 18, and 24 months from the date of manufacture. For products with a longer shelf life, analysis should be performed every 6 months after these periods are completed.
In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. Among the numerous tests carried out in this context, there are also long-term shelf-life stability testing services.
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