Intertek ASG Laboratory, Manchester, UK

Pharmaceutical Stability Storage and Analysis

Evaluation of pharmaceutical substance and product stability

Evaluation of the drug substance stability and product stability is an essential part of the development of a pharmaceutical product. Stability testing can provide information on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Data derived from a stability study enables recommended storage conditions, retest intervals and shelf lives to be established. Intertek ASG offers development of protocols designed to meet the ICH guideline requirements or, alternatively, can provide custom stability protocols to fulfil the specific stability study requirements of individual manufacturers.

Storage Conditions and Analysis Protocol

Intertek conducts stability studies (US, UK & Australia) in accordance with ICH Guidelines. Intertek offers a full range of stability storage conditions for the four World climatic zones, including accelerated / stress conditions using all standard ICH conditions and in addition controlled conditions from -80°C to +70°C and a range of humidity conditions from 15% RH to 80% RH (local facility offerings may differ). We can offer ICH photostability Option 1 and Option 2, and have capacity for custom conditions.

Stability services include:

Long-term stability testing
Intermediate stability testing
Accelerated stability testing
Tailored stability testing
Comparative stability testing
Forced degradation studies with characterisation of degradation products
Stability testing of APIs
Stability of Clinical Trial Material (CTM)
Pharmaceutical formulation component compatibility
Biopharmaceutical stability
Registration stability
Probe Stability

Stability services combined with advanced characterization capability position Intertek ASG 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.