Analysis laboratory / References: B.P.L. – B.P.F. – U.S.P. – P.E. – P.F.

LC² is able to carry out a very wide range of physical and chemical control tests thanks to our analysis equipment, which undergoes regular maintenance and qualification (including CLHP, Dissolutest, UV, IR). Our team is able to meet high requirement and specifications levels (e.g. comparative dissolution) in the context of quality control and stability studies.

Physical and chemical control tests

LC² undertakes identification and/or complete analysis of raw materials, loose materials, entrusted clinical batches, masked units and marketed end products (in the case of imports from outside the E.U.). In addition to analyses linked to clinical batches, the company plays a major supporting role in validating transferred analysis methods and in validating the cleaning of equipment and premises.

Stability studies

LC² is equipped with isolation chambers with controlled temperature and humidity. In every case, analysis tests are carried out on samples and the results are recorded in a stability report. Our experience and our equipment enable us to conduct the comparative stability studies (marketed form / masked form in the packaging used for your clinical studies) needed to establish sell-by-dates of treatment units.