Stability Program

Ameridose performs real-time stability indicating studies for all preparations. We maintain the most comprehensive real-time stability indicating studies in the country, following Federal Code of Regulations Title 21, Section 211 (GMPs) for testing. Our customers can enjoy complete confidence in the integrity of our preparations as well as documented exceptional shelf life.

Ameridose partners with only FDA-registered third party laboratories that adhere to Good Laboratory Practice (GLP) and cGMP guidelines. Our FDA-registered laboratory partners utilize HPLC and other stability indicating methodologies in the testing of all of our admixtures. Ameridose has conducted independent audits of each laboratory to ensure that these standards are met and maintained.

Our real-time stability studies utilize stability indicating methodology for the following criteria:
  • Shifts in pH
  • Homogeneity
  • Particulate Matter
  • Active Ingredient Drug Profiles
  • Storage Conditions Including Temperature Cycling
  • Container and Drug Interactions
  • Packaging and Shipping Studies
  • Light Sensitivity
  • Sterile Integrity of the Container/Closure System
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