Analytical Chemistry

Analytical chemistry is an integral part of our process development procedures, enjoying a close collaboration with organic chemistry and manufacturing. By providing an accurate picture of your API’s impurity profile, and by tracking impurities to their point of origin, analytical chemistry provides guidance for process development and setting of specifications. To our customers, this means proper quality is established from the start and maintained throughout the drug development process.

Our analytical chemistry specializations include:

Analytical Development
• Development of chromatographic assays and purity methods by HPLC and GC
• Development of preparative HPLC methods
• Validation of analytical methods according to ICH guidelines
• Isolation and structure elucidation of e.g. process impurities, degradation products or metabolites, analysis by accurate MS and NMR studies
• Sample preparation schemes for drug products and biological samples (urine, plasma)

Quality Control

  • Identity by 1H/13C-NMR and high resolution MS
  • Chromatographic determination of assay and potency including:
  •    Related substances
  •    Specific impurities (PGI and reagents)
  •    Enantiomeric purity/excess
  •    Residual solvents
  • Assay by 1H-NMR
  • Accurate mass determination (LC-MS-ToF)
  • Determination of volatiles (Karl-Fisher, Head space-GC)
  • Stability testing of drug substance and product according to ICH guidelines
  • Log D determination
  • Solubility determination
  • pH in solution
  • Pharmacopeial limit tests