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 and light. The data generated during stability testing helps to select appropriate formulations and packaging and establish a shelf life and recommended storage conditions for a drug product.

Pensatech Pharma conducts preliminary 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

  • Protocol design

  • Accelerated and long-term 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 or drug product, and assign a preliminary shelf life (re-test period).
 

For further information on our stability services or to request our equipment list, please contact us.