Stability Studies

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 retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.

HFR offer an informal stress test service or the full regulated service which complies to ICH guidelines. The client will be invited to approve the protocol before work starts, and will receive a final report, all supporting analytical work and analytical methods upon completion.