Analytical Method Development and Validation

Ferndale Contract Manufacturing offers extensive Analytical Method Development and Validation services to our clients. Our highly qualified analytical development team will provide comprehensive services for the efficient development, validation, and implementation of laboratory test methods and the generation of cGMP data for regulatory submissions.

As your strategic development partner, FCM’s analytical development group will design detailed protocols for method transfer, method development, validation, and analytical technology transfer based on the products phase in the development process.

  • Develop stability indicating assays for both API’s and preservatives
  • Perform forced degradation studies
  • Develop cleaning test procedures
  • Evaluate container closure systems

Analytical Capabilities

  • UPLC/HPLC capability PDA, RI, UV/VIS and ELSD detectors
  • GC direct injection and/Headspace analysis (FID and TCD detection)
  • Particle size distribution by Laser Diffraction
  • UV/VIS Spectrophometer
  • FTIR
  • Total Organic Carbon Analysis (TOC)
  • Wet analytical chemistry testing (auto-titrations, Karl Fischer water determination, loss on drying, sulfated ash, residue on ignition, TLC, melting point, etc.)
  • Residual Solvents Testing
  • Microbiological Testing
  • Viscosity (Brookfield HBDV –II cone and plate Rheometer)
  • In vitro release studies (IVRT)