Analytical Method Development and Validation
The Denison Quality Control Laboratory is equipped to perform numerous analytical techniques for In Process and Finished Product sample release. Testing includes, but is not limited to: pH, Specific Gravity, Viscosity, Refractive Index, Optical Rotation, Water Determination by Karl Fisher, FT-IR, UV-Vis, Titrimetry, HPLC-UV and HPLC-FID, and GC. In Process and Finished Product sample types can consist of Over-The-Counter Pharmaceuticals (OTC), cosmetic products, creams, lotions, gels, suspensions and solutions. Each Analytical Test Method (ATM) or Standard Operating Procedure (SOP) used for any analytical analysis follows current Good Documentation Practicecs (cGDP), current Good Lab Practices (cGLP), and all current USP/NF and ICH guidelines.
The Denison Analytical Services team can perform feasibility, optimization, and transfers of existing methodologies for your products. Our team also develops, validates, and troubleshoots new or challenging methods to ensure that testing runs as efficiently as possible. All test methods are developed following regulatory USP and FDA guidelines guaranteeing accurate and robust results.
Our Laboratory Information Management System (LIMS) used by the Denison Quality Control Laboratory records and tracks and saves all analytical testing information, and will generate an “Analytical Results Report” providing a valid and accurate report for our customers In Process and Finished Product release needs.
- Specific Gravity
- Refractive Index
- Optical Rotation
- Water Determination by Karl Fisher
Titrimetry Chromatographic Testing
- USP 2022 - Screening of Pathogens
GC Stability Testing
- Weight loss and any other applicable test methods.