Mylnefield Lipid Analysis provide a full complement of state-of-the-art cGMP stability storage and analytical testing resources and expertise to support commercial stability studies, release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems. Our stability storage facility can also be utilised for a range of other consumables that require stability storage and testing as part of product development.
Stability Storage Conditions Available:
25°C/ 60%RH (± 2°C/±5%RH) - Real time storage
40°C/ 75%RH (± 2°C/±5%RH) - Accelerated storage
GMP stability storage solutions include:
- Stability storage at typical ICH conditions for API and finished product
- Customized stability storage
- Accelerated stress studies at high temperature and humidity
- Fully mapped stability chambers
- 24-Hour continuous monitoring and recording of conditions
- Back-up power to stability chambers and monitoring system
- Controlled access facility
- Stability study protocol development
- Sample management during study
- In-house analytical testing and technical support throughout the stability study
- Dispatch to testing sites for subcontracted analytical testing
Mylnefield Lipid Analysis can write the stability storage protocol for approval by the customer before commencing the study, or can follow the customers own protocol.
Please contact Claire to discuss any stability study requirements.