From planning to final documentation: we are specialists in conducting stability tests on active pharmaceutical ingredients and finished medicinal products. This includes tests of in-use stability, transport stability (alternating temperature storage) and photostability as well as stress tests.
Not only do you benefit from our many years of expertise, but you also have a complete overview of costs at all times over the entire duration of a stability study.
Every order starts
with the determination of the required test samples and the creation of test plans. We then accompany you through the entire development and market phase (product life cycle). Regulatory stability tests, such as exploratory or confirmatory studies, are conducted under ICH conditions.
To verify the shelf life of all products on the market, we conduct on-going studies. Test samples are stored in qualified climate facilities equipped with alarm systems, where the required climate conditions are consistently controlled and recorded.
Photostability tests and stress tests under defined climatic conditions and exposure are also possible in our laboratory.
On request, we will also undertake the development and validation of specific methods for you. And of course you will find all relevant work steps – GMP-compliant – in our documentation!