Stability Programs
Vanton has the capacity and expertise to run complete stability programs at the R&D, pre-clinical, and clinical stages
As part of stability program, Vanton will:
- Develop the methods needed for stability-indicating parameters (e.g., assay, dissolution, content uniformity, water content, hardness, purity, physical, microbial, disintegration, etc.)
- Conduct full validation for a developed method or perform a method transfer from an existing method
- Establish stability protocols (timeline, sample information, methods, deviation control, OOS/OOT investigations, project management of the entire program, and full data reporting
- Maintain environmental chambers using a validated 24/7 monitoring system and backup power (various configurations covering most zones are available)
- Run stability methods per scheduling and present QA certified reports