BioScreen Inc.

Stability Offers Full Service Management Including Storage, Testing and Tracking to Meet USP and ICH Guidelines Including Method Development and Validation of the Active Ingredient Stability Indicating Assays

stabilitychambers

Stability Testing and Storage Services

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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

  • Freezer at -10° to -20°C
  • Freezer at -15° to -25°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
  • Photostability Chamber
  • Other Conditions Available on Request

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

 
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