HWI ANALYTIK

Development and validation

Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-​to-use products and 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) with a wide range of detection methods
• Spectroscopic methods
• Titrimetric methods

Purity testing

• Stability-​indicating testing for impurities of active ingredients and ready-​to-use products incl. peak-​purity evaluation
• Forced degradation studies to evaluate degradation paths and mechanisms
• Differentiation between degradation products and synthesis by-​products

Dissolution testing

• In vitro active-​ingredient dissolution of solid and semi-​solid dosage forms
• Evaluation of discriminating properties
• In vitro/in vivo correlation