Pharmaceutical Stability Studies

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.

Biopharmaceutical 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.

Storage Protocols
Intertek conducts stability studies (US, UK & Australia) in accordance with ICH Guidelines. 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* are offered. We can offer ICH photostability Option 1 and Option 2, and have capacity for custom conditions.

Stability services include:

• Stability of Clinical Trial Material (CTM)

• Pharmaceutical formulation component compatibility

• Biopharmaceutical stability

• Registration stability

• Probe stability

• Photostability

*Local facility offerings may differ