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Latest Headlines
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Analytical
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Services/Capabilities
 | | Active pharmaceutical ingredient and excipient testing according to official monographs (USP, EP, BP)
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| | Chemical/physical testing |
| | Drug substance characterization |
| | Identification and quantification of impurities and residual solvents |
| | Methods transfer |
| | Osmolality |
| | Raw material testing |
| | Release testing |
| | 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
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Instruments/Equipment View PDF
Liquid Chromatography
| | Waters Acquity UPLC |
| | Waters 2695 Alliance HPLCs |
Gas Chromatography
| | HP 6890 GC with 7694 Headspace Sampler and 7683 Injector |
Data Management
| | Empower II Chromatography Data System |
Dissolution (USP Apparatus I and Apparatus II)
| | VanKel VK7000 Dissolution Baths |
| | VanKel VK8000 Autosamplers |
| | VanKel VK650A and VK750D |
Particle Size Analysis
Additional Analytical Tools
| | AquaStar AQC34 Coulometric Karl Fischer Titrator with DO307 oven |
| | AquaStar AQV33 Volumetric Karl Fischer Titrator |
| | Brookfield LVT Dial Viscometer |
| | 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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