LSNE has full ICH stability study capabilities. We can manage every aspect of your ICH stability program — from storing product at ICH conditions and pulling samples to performing and managing all QC testing and writing interim and final reports
- Protocol Development
- Storage and Testing
- In-Use Stability
- Summary and Final Reports
LSNE’s deep understanding of both analytical testing and ICH stability studies gives us an extensive knowledge base — and the ability to help you build a stability program around your product’s exact requirements.
LSNE offers in-use stability studies, ICH stability studies and complete reporting of all data for your projects. Our facilities include ICH stability chambers appropriate for all standard storage conditions. We also offer Q1B photostability testing to support your NDA submissions. Working with LSNE can simplify your supply chain, and reduce the risk of complications from cold-shipping vials or transferring methods to another location.
New facility online 2018
- 4-fold capacity increase
- Expanded chromatography capabilities
- Expanded general chemistry capabilities
- Additional UPLC & HPLC units and detection capabilities
- Robust QA oversight
- Multiple chambers for each storage condition
- Full back-up generator in case of a power outage
- Storage conditions including: -20°C, 2-8°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH