Formulation Development

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Featured Publication
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology







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Analytical


Services/Capabilities
Active pharmaceutical ingredient and excipient testing according to official monographs (USP, EP, BP)
Analytical method development and qualification/validation
Chemical/physical testing
Chiral Analysis
Dissolution testing
Drug substance characterization
Identification and quantification of impurities and residual solvents
Methods transfer
Osmolality
Raw material testing
Release testing
Stability sample analysis
Comparator studies
Disintegration


Organization
Compound Expertise Preserved in Project Continuity
Distributed Project Lead Assignments
Flat Structures for Communication and Flexibility
Instrument Management
a. Calibration
b. Qualification
Lab Supplies Management and Manufacturing Sourcing
Laboratory Compliance and Training
Reference Standard Management
Stability and Laboratory Operations
Stability Study Management
a. All ICH conditions
b. GMP and development
c. Protocol development through report generation


Instruments/Equipment View PDF


Liquid Chromatography
Agilent 1100 HPLCs
Agilent 1200 HPLCs
Agilent UV/Vis, PDA, Fluorescence Detectors
Polymer Laboratories Evaporative Light scattering Detectors
Dionex Electrochemical Detector
Waters 2695 Alliance HPLCs


Gas Chromatography
HP 5890 series II GC with 7694
Headspace Sampler
HP 6890 GC with 7694 Headspace Sampler


Data Management
Varian Galaxie Chromatography Control and Data Acquisition System on isolated network
Empower II Chromatography Data System


Dissolution (USP Apparatus I and Apparatus II)
Distek Evolution 4300 Autosampler
Distek Premier 5100 Dissolution Baths
VanKel VK7000 Dissolution Baths
VanKel VK8000 Autosamplers
VanKel VK650A and VK750D


Particle Size Analysis
ATM Sonic Sifter
Beckman Coulter LS 13 320 Laser


Additional Analytical Tools
Agilent 8453 UV/Vis Spectrophotometer
AquaStar AQC34 Coulometric Karl Fischer Titrator with DO307 oven
Advanced Instruments Model 3320
AquaStar AQV33 Volumetric Karl Fischer Titrator
Accumet Model 15 pH Meter
Accumet Model AB15 pH Meter
Brookfield LVT Dial Viscometer
Brookfield RV-DVIII+ Rheometer (with small sample adapter)
Muffle furnace for ROI


Stability Chambers


c-GMP Stability Chambers (ICH Conditions)
Walk-in 25°C/60% RH Room


Reach-in Chambers
25°C/40% RH
30°C/40%RH
30°C/60%RH
30°C/65%RH
40°C/15%RH
Two (2) 40°C/75% RH
5°C


c-GMP Storage Refrigerators
Three (3) Puffer Hubbard (2-8°C)
Forma Scientific (-70°C)
Revco Ultima II (-20°C)
Warehouse Refrigerator (2°-8°C)-used by QA for sample retain storage


Data Handling
Stability Laboratory Information
Management (SLIM™) Software
Dedicated server for SLIM™




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