Pharmaceutical Stability, Storage and Testing Services

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Pharmaceutical Stability, Storage and Testing

Intertek has years of experience performing all types of analytical testing on a wide range of pharmaceutical substances and products. Intertek offers full stability study services comprising cGMP sample analysis and stability storage compliant to ICH requirements. Storage facilitities include multiple chambers covering a range of world climatic ICH storage conditions as well as a range of other environmental conditions required for specialty products.

Stability storage and analytical services include:

Long-term stability testing
Accelerated stability testing
Comparator stability testing
Forced degradation studies
Stability testing of Active Pharmaceutical Ingredient (API)
Clinical trial material (CTM) to support clinical trials
Pharmaceutical formulation component compatibility
Advanced characterization capability to identify degradation products from forced studies and to trouble-shoot unexpected problems from long term studies

Stability services combined with advanced characterization capability position Intertek ideally to undertake stability studies on complex products such as recombinant proteins. The same capability can be applied to the study of degradation pathways in stressed stability trials.

Stability Testing Locations:

Intertek QTI USA

Intertek ASG UK

Intertek PROBE Australia