Preliminary Stability Testing and Long Term Stability Studies
Stability testing plays a fundamental role in formulation development as it provides essential data on how the quality of a pharmaceutical product varies over time under the influence of different environmental factors such as temperature, humidity, oxygen and light. The data generated during stability testing help to select appropriate formulations and packaging and establish a shelf life and recommended storage conditions for a drug product.
Pensatech Pharma conducts stability testing at accelerated conditions to de-risk the development programme and rapidly identify drug product formulation and container closure system. Additionally, we offer long-term stability studies using our stability testing chambers covering climate zones I to IV to establish a shelf-life and recommended storage conditions for a drug product.
Capabilities in the field of stability studies:
- Protocol design
- ICH accelerated and long-term stability testing
- Excipient stability testing
- Drug substance stability testing
- Drug product stability testing
- Temperature cycling studies
We have comprehensive compendial testing capabilities for a wide range of dosage forms to assess your API, excipient or drug product, and assign a preliminary shelf-life (re-test period).
For further information on our stability services, please contact us.