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
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