Chemical molecules with low molecular weight or small size present in the composition of a material are more likely to be transferred to the environment in contact with the material, even more so if the material is aqueous. This type of transfer is called leaching.
Following an audit, a new regulation or the marketing of a new product, manufacturers are led to carry out release kinetics studies on their materials in order to observe the behavior of molecules over time and to evaluate the impact of the finished product on its environment (for example, the potential toxicological impact of a medical device in the human body).
To measure and evaluate these release kinetics, FILAB offers industrial companies tailor-made studies, adapted to the characteristics of the material and its environment. Based on a methodological approach, FILAB proceeds step by step:
1. The first step consists in carrying out a feasibility study and selecting the most suitable analytical method to quantify the molecules in the reproduced release environment: LC-MSMS, GCMS, CI… The selected method is then checked according to its sensitivity (detection limit and quantification limit) and according to the responses of the molecules in presence.
2. The 2nd step is the validation of the analytical method. According to the standards in force in the sector concerned by the study, for example the ICH Q2 standard for the pharmaceutical and medical sectors, FILAB provides its client with an analytical validation plan before launching the tests.
3. Finally, the release kinetics study is the third step. After validation with the client on the duration and number of samples to be taken, quantitative analysis are performed in the laboratory under the product’s release conditions. Following the study, a debriefing meeting is organized with our client in order to present all the data, and the interpretation of the results of the study.
