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 Pharmaceutical Services offer 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*. 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

*Local facility offerings may differ

Biopharmaceutical and Complex Product Stability Services

Biopharmaceuticals are particularly sensitive to environmental factors, making strict storage conditions necessary for the maintenance of biological activity and product integrity. Advanced characterisation capability position Intertek ideally to undertake stability studies on complex products such as recombinant proteins.

Analytical Method Development and Validation

Intertek offers a full method development and validation service covering a wide range of analytical technologies. Method Transfer can be conducted in conjunction with our customer’s originating laboratory.