Stability and forced degradation
Adequate chemical stability is key for the progress of any New Chemical Entity
- Chemical stability under any condition: stability is studied in solution (in any solvent) at defined temperature and times, individually or in a high throughput setting. The proportion of degradation compounds is reported graphically and in table format. Aqueous stability at pH 2 and 7.4 are the standard conditions in Drug Discovery projects.
- Forced degradation studies: Standard tests in acidic, basic, oxidative and heating conditions are assayed at different times (ICH guidelines) to reach a minimum degradation profile. The degradation compounds are identified by HPLC and elucidated by MS, with proposal of structures that are later on synthesized by our Synthetic Chemistry experts and finally characterized using both HPLC/MS and NMR. This study helps to determine a compound intrinsic stability and to establish its degradation pathways, as well as to validate adequate stability-indicating methods.
- Impurity elucidation, identification and characterization. Identification and characterization of substance impurities present in any small molecule or in any step of its synthetic process. Our team expertise together with state-of-the-art equipment (Agilent’s HPLC/QTOF 6540, Ultimate3000-LXQ), allows the separation (through preparative HPLC) and accurate mass determination of the different impurities and their fragmentations. The proposed impurities are then synthesized by our Synthetic Chemistry experts and compared with the real samples, after which the complete characterization of matching samples using both HPLC/MS and NMR is done.
Turnaround time: 3 days for chemical stability and 4 weeks for forced degradation studies