Stability Testing Services

Shelf life testing is an essential part of the development and maintenece of drugs, OTCs, and cosmetics.  BioScreen has of 30 years of testing the shelf lives for everything from color cosmetics to cytotoxic chemotherapy APIs and Drug products.  Our data has been used to support numerous product registrations and NDA filings.  BioScreen's large volume of chambers and wide range of conditions has us prepared to take on any long or short term shelf life or period after opening study.  Please contact us today for a quote.

Benefits of Stability Services

  • Validated Stability Chambers per FDA and ICH Guidelines
  • Back-up Power
  • Stability Tracking
  • New State-of-the-Art Storage Space
  • Retention Samples Maintenance and Secure Storage
  • Testing of Active Pharmaceutical Ingredients and Finished Products
  • DEA Registered for Controlled Drug Substances

Stability Testing Services May Include:

  • Complete Method Development or Transfer and Validation
  • Active Ingredients by HPLC, GC and other Analyses
  • Antimicrobial Effectiveness Tests
  • Color, Odor and Appearance
  • Endotoxin Testing
  • Microbial Limits
  • Moisture/Solids
  • BP, EP, JP and USP Monograph Tests

 

 

 
  • Particulate Matter
  • pH
  • Preservative Actives
  • Specific Gravity
  • Sterility Tests
  • Viscosity
  • Weight Change
  • Freeze Thaw Analysis
  • Period After Opening

 

 

Stability Storage Conditions

  • Ultra Low Freezer at -84° to -66°C
  • Freezer at -20° to -10°C
  • Freezer at -25° to -15°C
  • Refrigerated at 2° to 8°C
  • 25° ± 2°C with Ambient Humidity
  • 25° ± 2°C with 60% ± 5% Relative Humidity
  • 30° ± 2°C with 65% ± 5% Relative Humidity
  • Accelerated at 40° ± 2°C Ambient Humidity
  • Accelerated at 40° ± 2°C with 75% ± 5% Relative Humidity
  • Accelerated at 45° ± 2°C with Ambient Humidity
  • Accelerated at 50° ± 2°C with Ambient Humidity
  • Photostability Chamber
  • Other Conditions Available on Request

For a written price quotation please use our online quote form or call 310-214-0043.