Real-time or long-term stability studies are carried out to determine the expected shelf life and physical, chemical, biological and microbiological properties of products during and after their storage periods under expected storage conditions in the target market.
-testleri.jpg "Short Term Stability (Accelerated Stability) Tests")
For example, the stability of finished pharmaceutical products depends on environmental factors such as ambient temperature, humidity and light on the one hand, and product-related factors on the other, such as the chemical and physical properties of the active substance and pharmaceutical excipients, dosage form and composition, production process, structure of the container closure system and depends on the characteristics of the packaging materials.
For established drug substances in conventional dosage forms, data on the decomposition process and degradability of the active substance are often available in conjunction with adequate analytical methods. Therefore, stability studies are limited to dosage forms.
Sometimes, as part of a formal stability testing program , accelerated stability or short-term stability tests are conducted to increase the rate of chemical degradation and physical change of a drug under exaggerated storage conditions. Data obtained in this way are used in addition to data from real-time stability studies to evaluate long-term chemical effects under unaccelerated conditions and to assess the effects of short-term transport outside of storage conditions.
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 short-term stability (accelerated stability) testing services.
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