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.

The Denison Quality Control Laboratory is also equipped to run Total Organic Carbon (TOC) and Conductivity analysis on certain water/solution samples.

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.

Testing Includes:

Physical Testing

  • pH
  • Specific Gravity
  • Viscosity
  • 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.