Stability Storage and Testing Program

Stability Testing Services

Shelf-life testing is an essential part of the development and maintenance of drugs, OTCs, and APIs. Chromak Research has of 30 years of testing the shelf lives for APIs and Drug products. Chromak Research Testing Laboratory is equipped with full range stability chambers for storage of samples for Expiration Dating.Our data has been used to support numerous product registrations and NDA filings.Chromak Research stores samples and provides testing on these samples at the specified time intervals when test services are required by its Clients. Please contact us today for a quote.

Benefits of Chromak Services

  • Validated Stability Chambers per FDA and ICH Guidelines
  • 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 Storage Conditions

  • 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
  • Other Conditions Available on Request