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Main page / Services / Analytical services

Analytical services

Since 2005, Confab offers their clients the possibility of on-site analytical services.  Our laboratory is cGMP compliant and is regularly inspected by regulatory agencies (ex. TPD).  In 2009, the analytical laboratory was successfully inspected by the FDA.  This milestone has ensured efficiency for all Confab clients.


Our Analytical Services include:

Complete compendial testing (according to USP/NF, BP, EP, etc.), including:

  • Raw material release testing (including Identification, Assay, Water, Loss on drying, Heavy Metals, etc.)
  • Finished product release testing (including Assay, Content Uniformity, Dissolution, Impurities, Physical testing, etc.)
  • Container/Packaging release testing
  • Other tests according to client’s procedures or in house methods

 

     Instrumentation:

  • HPLC (with UV, refractive index or fluorescence detection)
  • UPLC (with UV detection)
  • GC (FID, TCD, Headspace)
  • Dissolution (USP methods I and II)
  • Spectroscopy (UV and IR)
  • Atomic Absorption
  • Moisture analysis (Karl Fischer)
  • Polarimeter
  • Potentiometric Titrator
  • Refractive Index
  • Viscosimeter
  • Physical testing and Wet Chemistry

 

 

Stability storage according to ICH guidelines:

  • Confab has 4 stability chambers:
    • Standard (25°C/60% RH)
    • Intermediate (30°C/65% RH)
    • Accelerated (40°C/75% RH)
    • Zone 4 for tropical conditions (30°C/75% RH)

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Also available:

  • Analytical method transfer
  • Analytical method development and validation
  • Cleaning validation
  • Process validation
  • Enzyme testing