Overview
From discovery candidates to clinical trial materials, BioDuro’s analytical team provides the necessary data needed throughout the development process. BioDuro’s cGMP analytical laboratories facilitate integrated and efficient project support with analytical scientist actively engaging with clients and providing analyses to Formulations and Manufacturing departments. Equipped with state-of-the-art instruments, BioDuro’s experienced analytical team ensures quality services through Phase III studies.
The BioDuro Advantage
- Strict adherence to ICH and cGMP guidelines
- Continuity in analytical work – training and transfer of analytical methods to Quality Control
- Engagement in project management throughout the development process
- Development of robust and easily transferrable methods
Services
Our analytical team provides a broad range of services including:
Capabilities
Our laboratories host state-of-the-art instruments enabling the following:
- Chromatography
- Spectroscopy
- Dissolution and Disintegration Testing
- Karl Fischer
- Physical Testing
- Particle Analysis
- Thermal Analysis
- Microscopy
Equipment
Liquid Chromatography:
- Dionex Corona Charged Aerosol Detector
- Waters UV/Vis, PDA Detector
- Waters, Agilent HPLC
- Waters UPLC
Gas Chromatography:
- Agilent G6890, G1888 Headspace Sampler
Spectometry:
- Agilent Cary 60 UV-Vis Spectrophotometer
- Perkin-Elmer Spectrum 100 FTIR
- Molecular Devices Spectramax
Particle Sizing:
Thermal Analysis:
- TA Instruments Modulated DSC w/Autosampler
- Perkin-Elmer Pyris Thermogravimetric Analyzer
Dissolution and Disintegration:
- Agilent Dissolution Test Station w/Autosampler
- Hanson Research QC-21 Disintegration Test Systems
- Vankel Enhancer Cell
- Hanson Research Ointment Disk
Other:
- Mettler Toledo DL38 Karl Fischer Titrator
- Leica Polarizing Light Microscope
- Varian/Venkel Hardness Tester
- Erweka Friability Tester
- Thermo Scientific Savant High Speed Solvent Evaporator
- Rigaku X-Ray Powder Diffraction Analyzer
