The Center for Advanced Drug Development performs a wide range of assays to obtain data for pre-approved active pharmaceutical ingredients, new molecular entities, drug products and excipients.

Services include:

• Stability-indicating assay method development and validation
• Development and validation of assays for dissolution
• Technical transfer of analytical methods
• Dissolution, using USP Apparatus 1 and 2, single point and profile testing
• Preformulation studies
• Excipient screening and selection
• Physical characterization of polymorphs and amorphous material
• Quality control analysis
• Active pharmaceutical ingredient and excipient testing according to official monographs (USP-NF, EP, BP)
• Residual solvent testing, OVI I, IV and V
• Long and short term stability studies per ICH guidelines

Capabilities | Method Development and Validation |Stability Studies
Analytical Instrumentation | Other Services | Assurances | Contact | Home

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