Analytical Development and expertise

Analytical Development and expertise
Product Description

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment) and Extractable Leachable (EL) capabilities.
Equipment:
Centrifugation for heat-sensitive productsSurface area and pore size analyzer (BET)Friability, disintegration, viscometry, etc.Brookfield viscometerUV-Visible and IR/NIR spectrophotometers (Perkin Elmer)Karl Fisher titrator (Mettler)PotentiometryLaser diffraction particle size analysis (Malvern)Total organic carbon (TOC) analyzerHPLC/UHPLC (water/agilent) with PDA multiwavelength detector, UV detector, refractometerGas chromatography (GC) detectors: FID & TCDUV On-/Offline automated dissolution testing (SOTAX)Automatic Mortar Grinder, Stability cambers, Vitek®, BET Surface Area and Pore Size Analyzer.

SKYEPHARMA PRODUCTION S.A.S

  • FR
  • 2017
    On CPHI since

SKYEPHARMA PRODUCTION S.A.S

  • FR
  • 2017
    On CPHI since

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