Analytical Services

From proof of concept to clinical production, our analytical services have you covered.

CritiTech provides a robust suite of analytical and material characterization 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.  These services are offered to support drug development projects, but many are also available on an individual basis. For more information on ala carte analytical testing services, please request a quote.

Analytical and Material Characterization Services

  • Analytical Method Development
  • Analytical Method Validation
  • Formulation Development
  • Particle Size Analysis
    • Laser Diffraction (Liquid and Dry Powder Dispersion)
    • Laser Obscuration
  • BET Sorptometry – Surface Area Determination
    • SAA
    • Porosity
  • 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
  • Bulk and Tapped Density
  • ICH Stability
    • Analytical Testing In-house
    • Storage Outsourced Locally

CritiTech Analytical and Material Characterization Systems

JEOL NeoScope Scanning Electron Microscope

  • Compact Benchtop SEM with automated settings for biological and materials samples
  • High resolution and large depth of field complement optical microscopes or SEM instruments in the lab
  • X10 — 20,000 magnification without lens change
  • Automatic and manual control with pre-stored recipes
  • High and low vacuum modes
  • No special sample preparation, such as coating and drying, for conductive and non-conductive samples
  • Secondary electron and backscattered electron imaging
  • Three selectable accelerating voltages
  • Sample loading to imaging in less than three minutes

Quantachrome NOVATouch LX2 Surface Area Analyzer (SAA)

  • 4 Degassing Ports and 2 analysis stations
  • Surface area analysis, mesopore size distribution, and standard micropore analysis

Malvern MasterSizer 3000 Particle Size Analyzer (PSA)

  • Aero S, Hydro MV, and Hydro SV dispersion units.
  • 0.01-3500 um range
  • 21CFR Part 211 Compliant