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Analytical Development & Stability Testing

We utilize a large climate-controlled storage capacity. The facilities are secure, with multiple levels of independent security measures, automatic protection measures for samples in the event of system malfunction, available troubleshooting climatic enclosures and an internal metrology and validation unit (IQ/OQ/PQ).

Expertise

  • Engineering and validation of analytical techniques
  • Stability studies using ICH conditions (3 references)
  • Specific stability studies by client request
  • Optimized and integrated management of sample flow

Environment / Laboratory

  • 500 m² of laboratory space
    (not counting relocated production facilities)
  • Additional sample storage area for ICH-specific conditions
    (ATA 30m3)
  • Recent and high-performance equipment used for our analytical studies
    – HPLC (Merck)
    – CPG (headspace) (acquisition 2010)
    – UV-visible
    – IR
    – Karl Fischer
    – ….
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