Development and validation
Identity testing, assay, purity testing and in vitro dissolution
Development and validation
We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.
Development reports, validation plans and validation reports can be prepared in English, German or French and integrated directly in your marketing-authorisation dossier.
Identity testing and assay
- Chromatography methods (HPLC/UPLC/GC/TLC) with a wide range of detection methods
- LC-MS, GC-MS
- Electrophoresis with different detection methods
- Spectroscopic methods
- Titrimetric methods
Purity testing
- Stability-indicating testing for impurities of active ingredients and finished products incl. peak-purity evaluation
- Forced degradation studies to evaluate degradation paths and mechanisms
- Differentiation between degradation products and synthesis by-products
In vitro dissolution testing
- In vitro active-ingredient dissolution of solid and semi-solid dosage forms
- Franz cell
- Evaluation of discriminating properties
- In vitro/in vivo correlation
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