Analytical Development
Overview
- BioDuro - Sundia’s Analytical research and development (ARD) team offers high-quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, CMC dossier preparation services.
BioDuro-Sundia Advantage
- One-stop service with high quality & fast turnaround time
- Strong experience & regulatory knowledge for IND, NDA & ANDA Projects.
- Successful track record of submission in both US & China FDA.
- Cost effective & high quality.
Service Areas
- cGMP Compliant Method Development & Validation
- Starting materials
- Intermediates
- APIs
- Qualification of reference standards
- API Characterization
- Physical properties
- Impurities identification
- Structure elucidation & confirmation
- Chemical characterization
- API Testing & Release
- Drug Substance specification support
- Analytical support for Formulation Development
- Stability Management & Testing (according to ICH/FDA/CFDA guidelines)
- Stability indicating method validation & transfer.
- Preparation & Approval of stability protocol
- Sample management
- Sample testing
- Data & trend analysis & preparation
- analytical training, documentation & internal audit
- Stability Conditions include
- -20°C
- 5°C
- 25°C/60%RH
- 30°C/65%RH
- 30°C/60%RH
- 40°C/75%RH
- 50°C
- Photostability
Overview
- Full analytical services enabling an integrated and efficient development path. Method development and in-process testing activities guided by industry experts. BioDuro-Sundia’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, our experienced analytical team ensures quality services through Phase III studies.
BioDuro-Sundia 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
Service Areas
- Method Evaluation Development & Optimization
- Method Transfer & Validation
- Drug Product specification & Support
- Stability Studies
- Siemens APOGEE Monitoring System
- Full generator backup
- Drug product, drug substance, placebo
- Testing Capabilities
- XRPD
- Dissolution
- Karl Fisher
- Drug Product Testing & Release
- Assay/impurities testing & method validation
- Dissolution testing and method validation
- Blend/content uniformity testing & method validation
- Cleaning verification/validation
- Protocol design
- Long term stability testing
- In-use stability testing
- Accelerated stability testing
- Forced degradation studies
- Temperature cycling
- Storage conditions
- 25ºC/60% RH
- 30ºC/65% RH
- 40ºC/75% RH
- 2-8ºC
- -20ºC
- Siemens APOGEE Monitoring System
- Full generator backup
- Drug product, drug substance, placebo
- Testing Capabilities
- XRPD
- Dissolution
- Karl Fisher
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
- Malvern Mastersizer 2000
- Thermal Analysis
- TA Instruments Modulated DSC w/Autosampler
- Perkin-Elmer Pyris Thermogravimetric Analyzer
- Dissolution & 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