A Premier CDMO. FDA Registration #1210580.
Contact us

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:

  • HPLC-UV
  • USP 2022 - Screening of Pathogens

GC Stability Testing

  • Weight loss and any other applicable test methods.

Learn More About our Analytical Services

FAQ

What is Lorem Ipsum?

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. 

Why do we use it?

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using ‘Content here, content here’, making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for ‘lorem ipsum’ will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

Where does it come from?

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old.