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Stability Testing

Whether your product, container or drug substance is investigational, on the market or in the approval process, Celsis Analytical Services has the experience, expertise and knowledge to assist you in fulfiling your stability testing requirements.

Highlights of our Stability Testing program:

  • Independent Alarmed Monitoring System
  • Clinical and Finished-Product Programs
  • Secured Storage Area
  • Sample Management Software
  • DEA Controlled Substance License “Schedule I-V”
  • UV/Cool White Photostability (Temperature Controlled)
  • Temperature Cycling
  • Protocol Design
  • Independent Backup Power Supply

Celsis maintains Standard Operating Procedures for many stability testing conditions, including:

  • General stability requirements and operations
  • Labeling, handling and storage of stability samples
  • Computerized sample entry
  • Computerized reporting of stability tests
  • Quality Control program for stability storage units/areas

These SOPs are available for your review. Please contact Celsis Analytical Services to arrange an inspection of our stability storage equipment and laboratories.

 

Related Links

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