Pharmaceutical analysis
SERVICES


  • Development, validation and transfer of analytical methods according to ICH or VICH guidelines
  • Stability studies on Drug Substances and Medicinal Products under ICH or VICH conditions
  • Photostability
  • In-use stability studies
  • Establishment of monograph for NCE and for Herbal Drugs
  • Stability testing of finished products for use in clinical trials
  • Analysis for cleaning and process validation
  • Product/Package interactions
  • Determination of residual solvents
  • Identification of impurities
  • Limit test for genotoxic impurities (according to CPMP / SWP/5199/02)
  • Microbiological assays of antibiotics
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