Compendial & Non-Compendial Testing

Compendial & Non-Compendial Testing (Pharmacopeial)

Compendial monograph (pharmacopeial) tests are standardized methods and specification testing for generic pharmaceutical raw materials and finished products.  They are utilized as a basic requirement needed for most regulatory submissions around the world.  We can use your pre-validated methods or can develop and validate in-house methods.  You will receive a detailed report along with your certificate of analysis (C of A) for your raw materials or products.

Standardized Methods Used

  • US Pharmacopeia-National Formulary (USP/NF)
  • European Pharmacopoeia (EP)
  • Japanese Pharmacopoeia (JP)
  • British Pharmacopoeia (BP)
  • Food Chemical Codex (FCC)
  • American Chemical Society (ACS)
  • Other International Pharmacopeial Methods
Compendial Testing Applications

  • Raw material testing (USP/NF, EP, JP, BP)
  • Drug Substance Reference Standards Characterization Studies
  • ICH Stability Studies (Raw Material & Finished Products)
  • Dissolution Studies
  • Particle Size Distribution Determination
  • Assay & Stability Indicating Methods
  • Microbiological Testing
Applications for Non-Compendial Testing

  • Method Verification & Transfers
  • Raw Material Verification
  • Assay determination
  • Impurity & Contaminant Identification
  • Stability & Disintegration Studies
  • API Ingredient Characterization
  • Investigative Problem Solving
  • Trace Impurities Testing

Avomeen’s drug product development laboratory can handle even the most complex projects.

For More Information:
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Email: scientist@avomeen.com
Call: 1-800-930-5450

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