Stability testing
and storage

AZ Biopharm is a GLP/GMP-certified test facility

Stability testing and storage

Stability

After assessing the respective problem, we coordinate an individual stability programme together with our customer and develop it according to the customer-specific requirements.

Our range of services therefore also includes long-term, short-term and in-use studies.

Depending on the galenic nature of a medicine, an active ingredient may become unstable if exposed to light and thus lose its effect. Determination of photostability is part of the range of services our analytical laboratory offers and it always takes place according to ICH guideline Q1b.

 

Storage

Guideline Q1A details climate values for long-term, expedited and intermediate tests, that must be complied with in the stability tests of medicinal products. Pursuant to this ICH Guideline Q1A or pursuant to customer-specific requirements, our accredited laboratory has a wide range of storage options for:

  • 25°C/60%rh; 30°C/65%rh; 40°C/75%rh; 2-8°C; -20°C; -70°C

Storage is offered here either with or without analysis. All equipment and climatic chambers are controlled by an alarm system.