© Novanalitica S.r.l.s.
Our expertise
- Development and validation of analytical methods indicator of stability for the control of active pharmaceutical ingredients (APIs) and drug products (DP).
- Set up of stability studies protocols according to the international guidelines (ICH).
- Forced degradation studies of APIs, isolation, characterisation, and synthesis of degradation products.
- Impurity profiling (LC-UV-HRMS).
- Physicochemical characterisation of new chemical entities: e.g. solubility (Shake flask and Multiscreen), Log P
- Metabolic stability in different matrices and species (microsomes, S9, plasma)
- In vitro metabolite profiling by HRMS and phenotyping
- Bioanalytical methods development and validation for in vivo DMPK
