Keane Analytical Ltd    Consultant Chemical Analysts

The ICH guideline on stability studies has the following definition:

"The purpose of stability testing is to provide evidence 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, and to establish a shelf life for the drug substance or drug product and recommend storage conditions for the drug substance or drug product".


    


At Keane Analytical, we have extensive experience of the setting up and management of our customers' stability trials. We understand the importance of obtaining accurate results for regulatory submissions and all our staff operate to a high quality standard to meet the levels required. This is an area in which it is cost effective to outsource the storage and analysis and we can ensure our customers receive the best service.

By contracting out your stability storage and testing to Keane Analytical, you can be assured that the timeframes for analysis will be met.

   

• Storage totalling over 30,000   litres
• ICH conditions
• Customer specific requirements
• Cabinets calibrated regularly
• Monitored 24 hours a day
• Project management of stability trials
• Computer trend analysis of   results