Stability Testing and Stability Storage
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.
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
MLA can write the stability storage protocol for approval by the customer before commencing the study, or alternatively MLA can follow the customers own protocol.
Please contact Claire Traynor to discuss any stability study requirements.