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Demonstrating stability and shelf life

As part of the marketing authorisation process of medicines, the stability of the finished product and of the active ingredients must be demonstrated and documented according to the applicable ICH guidelines. PhytoLab is the right partner for this: we conduct shelf life studies on finished medicines and on the corresponding active constituents. In doing so, we store your test specimens in accordance with ICH conditions.

Diverse storage conditions

Our range of services includes long-term studies for all relevant climatic zones, as well as refrigerator and freezer storage. Of course we also simulate the breaking open of the respective medicine as part of determining in use-stability. In addition to the stability testing that is required in the approval procedure, we also offer you the ongoing stability tests, which are now increasingly requested.