Laboratory
Stability testing

Stability studies for quality control

For more than 30 years, we have been conducting stability studies of pharmaceutical products under GMP conditions and in compliance with ICH guidelines.

Our range of services

We offer stability tests for finished medicinal products and active ingredients in accordance with the valid guidelines in the European and international environment. We provide you with customised solutions for all dosage forms and applications, from preclinical development to the authorised medicinal product on the market.

We have many years of experience in conducting stability studies and take over the entire stability management. This includes the preparation of result reports, assessments and tabular and graphical evaluations. If required, we can enter the results directly into your templates and/or CTD modules.

Our competent team develops matrixing and bracketing designs. We also advise you on stability concepts and runtime specifications in product development and lifecycle management.

Stability studies

We conduct the following stability studies:

Long-term stability studies
Shelf-life stability studies
Photostability studies
Studies on bulk stability
Studies on the accelerated degradation of active ingredients and finished medicinal products

Stability storage

Your samples are in safe hands with us. We offer GMP-compliant storage at various temperatures and humidity conditions, including

25 °C / 60 % relative humidity,
30 °C / 65 % relative humidity,
30 °C / 75 % relative humidity,
40 °C / 75 % relative humidity,
2-8 °C,
as well as deep-freeze storage from -18 °C up to -80 °C.

If you require special climate conditions, we will be happy to implement them according to your specifications. Our state-of-the-art climate chambers and cabinets are monitored around the clock in compliance with GMP.

We have extensive capacity in our climate chambers to store even large registration stabilities, if necessary at short notice.