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Stability and forced degradation studies

Selvita offers a comprehensive set of services related to the stability studies for different formulations, drug substances or drug product with different dosage forms. The scope of stability studies offered includes preparation of a stability study protocol, study monitoring and a complete analytical testing needed for particular drug, continuous and summary reporting of stability results.

The test conditions available on site are: 25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH and comply with the ICH requirements. Upon client’s request, we can also conduct stability studies in other conditions in the Binder stability chambers. In addition to stability studies, we also carry out photostability, accelerated stability and forced degradation studies.

The physical and chemical stresses include especially: exposure to heat, exposure to light (UV/VIS), acidic, alkaline and oxidizing stresses, exposure to elevated temperatures and humidity of the environment. Accelerated stability and forced degradation studies are usually part of development of a new method, but they can also support stability studies for different formulations of a drug product.