Cebiphar is a reference service provider to R&D laboratories in the pharmaceutical and cosmetic industry for analytical development. Our objective is to provide our clients with the most tailored solution at each stage of their projects, and to ensure regulatory compliance.

Preparation of monographs and scientific data of APIs, excipients, and packaging material

Development, validation and transfer of physicochemical methods

  • Stability indicating analytical methods for APIs and preservatives
  • Discriminating dissolution tests
  • Assay of impurities:
    • Related substances (synthesis impurities, degradation products)
    • Genotoxic impurities
    • Residual solvents
    • Catalysts/ mineral impurities

Development, validation and transfer of microbiological methods

  • Microbiological assay of antibiotics
  • Within ACM Pharma laboratory:
    • Microbiological quality of sterile and non-sterile products
    • Efficacy of antimicrobial preservation (challenge tests)
    • Bacterial and fungal identification
    • Activity of biocides and preservatives
    • Bacterial endotoxins

Products/container interaction studies: extraction studies (extractibles) and migration (leachables), sorption studies

We also propose the following studies in partnership:

  • Identification, synthesis and qualification of impurities
  • Preparation/qualification of reference substances
  • Powder characterisation: granulometry, thermic analysis, X-rays, specific surface
  • Multi-elements ICP/MS assay