Understanding Stability Testing Services
Leachables studies want to follow the migration behavior of any material impurity being introduced into the drug product as a result of the interaction with the materials of construct during the intended use. The conditions of “intended use” for leachable studies often refer to the storage conditions, selected for the stability studies for the API.
Toxikon has a large capacity for storing leachable samples under temperature and humidity controlled conditions in climatic chambers. All chambers are fully qualified (IQ/OQ/PQ) and are temperature mapped. The climatic chambers are monitored online.
Toxikon can offer a broad variety of storage conditions, ranging from -80°C up to 70°C across different climatic zones and storage requirements. In addition, our stability services can also be offered for API’s and finished product testing using pre-defined protocols. These services include storage, analyses and reporting under full compliance with cGMP and ICH guidelines.
- Organic analysis by GC, GC/MS, HPLC, LC/MS, LC/MS/MS
- Elemental analysis by ICP, GFAA and cold vapor AA
- FTIR and UV/Vis Spectroscopy
- pH and Total Organic Carbon (TOC) provide non-specific indications of chemicalmigration
- Ion chromatography
- Particle sizing analysis
- Karl Fischer
Toxikon’s Expertise in Stability Testing
Toxikon can offer you services that will facilitate product development by reducing the potential for product and process failure. By partnering with us and learning your application, Toxikon provides specific solutions and results that will facilitate development.