CritiTech Particle Engineering Solutions (CT PES) provides a robust suite of non-GMP and cGMP material characterization and analytical services to support our clients drug development projects from proof-of-concept through clinical production.  Our testing data and documentation is reviewed by experienced technical and quality staff to ensure they can be used to support regulatory filings.  The following is a list of CT PES’ material characterization and analytical services:

  • Particle Size Analysis
    • Laser Diffraction (Liquid and Dry Powder Dispersion)
    • Laser Obscuration
  • Sorptometry – Surface Area Determination
    • BET
  • Residual Solvent Determination
    • Gas Chromatography
  • Moisture Determination
    • Karl Fischer Titration
    • Loss on Drying
  • Crystalline Phase Determination
    • X-Ray Powder Diffraction
  • Calorimetry
    • DSC
  • Imaging
    • Scanning Electron Microscopy
    • Transmission Electron Microscopy
    • Optical Microscopy with Digital Image Analysis
  • Quantification and Purity
    • HPLC (ELSD, PDA & UV-Vis)
    • UV/Vis Spectrophotometry
    • GC (FID & ECD)
  • Identification
    • FTIR
    • HPLC
    • UV/Vis Spectrophotometry
  •  Dissolution
    • USP Apparatus 1/2
  • Potentiometric Titration
  • Optical Activity
    • Polarimetry
  • Physical Chemical Properties
    • LogP
    • LogD
    • pKa
    • pH Dependent Solubility Determination
  • ICH Stability
    • Analytical Testing In-house
    • Storage Outsourced Locally