Stability Testing Services

Given BioScreen's wide ranging capabilities in Microbiology and Analytical chemistry BioScreen is the ideal partner for your next stability study.  Our large volume of chambers and wide range of conditions has BioScreen prepared to take on most any short or long term shelf life or period after opening study.  

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.