Analytical development and stability studies

Working with a strategic partner, Cyton provides a comprehensive service for analytical development and stability studies to support pharmaceutical product registration.

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
  • 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

Stability studies

Our partner has a significant climatic chambers storage capacity, and can perform stability studies in the course of development projects or post-marketing studies. With regards to medicines, stability programs are carried out in strict compliance with ICH-VICH guidelines.

  • Studies for APIs, bulk products and finished products
  • All ICH-VICH conditions, long term, intermediary and accelerated conditions
  • Pre-stability studies for formulation screening
  • Freezing/defrosting cycles
  • Photostability studies
  • Support studies for transport conditions

Related pages:

Cleaning Validation

Manufacturing & Quality Projects