Stability

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

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.

Case Studies

In 2009, Mylnefield Lipid Analysis was approached by Natural Nutrition (subsequently EPAX and then Trygg Pharma), to conduct stability testing throughout shelf life analysis for a newly developed compound.

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