The actual stability of a pharmaceutical product is highly dependent on the formulation and packaging closure system chosen by the manufacturer. Therefore, the issue of stability should be given high priority during product development stages, eg selection of excipients, determination of their levels, process development. The possible interaction of the drug product with the packaging material in which it will be delivered, transported and stored during its shelf life must also be considered.
Stability tests are a series of tests for obtaining information about the stability of a pharmaceutical product to determine shelf life and expiry times under certain packaging and storage conditions.
Open package stability test is a test method that involves waiting for a certain period of time at the storage temperature declared by the manufacturer in order to determine the shelf life of a medical or cosmetic product after opening. Open package stability tests are also carried out for biocidal products. For the stability tests of the open package, the biocidal product is tested by keeping the package open in air-conditioning cabinets at a temperature of 25 degrees (plus / minus 2 degrees) for the duration of use after the product is opened. These tests are carried out in 12-month periods up to 3 months.
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 open packaging stability testing services.
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