Accelerated stability study
Atypical stability conditions
Unique approach: flexible protocol
Shelf life prediction based on 2 weeks stability
Information about the stability of the drug substance (new chemical entity) or preliminary drug product formulations are an integral part of the systematic approach towards stability evaluation.
Accelerated stability studies are performed to establish at short notice what the intrinsic stability of your drug substance or formulation is, and to help predict what can be expected during the formal long term stability study.
Based on our experience, we select the most relevant storage conditions to evaluate thermal stability and sensitivity to moisture. Using our software, we accurately predict the shelf life of the new chemical entity or its formulation. Since the calculation respects the ICHQ1E guideline, results can be implemented in the registration file.
Together with the customer, we define a flexible protocol, including relevant testing such as: pH, assay, purity, dissolution testing, water content, particle size determination, chiral purity, disintegration, hardness, friability, compendial test on coloration, aspect, and others as required.
As it is the aim in this research phase of development to collect as much information as possible in a short time, we adapt the accelerated stability study protocol based on the intermediate results we obtain. Our strategy is that the protocol has to follow the intermediate results of the drug substance and not that the product has to follow the protocol!
This cost and time-saving approach is unique, delivering the most valuable information about stability and shelf life.