Impurity Testing Laboratory

Let our deformulation and failure analysis experts isolate and identify any impurities or unknown compounds in your product or raw materials

Avomeen’s GMP compliant laboratories specialize in unknown material analysis of contaminants, impurities, trace materials, and residuals within a sample or product. Our scientists can also test for product degradation over time and identify any process impurities present.

Manufacturers take advantage of Avomeen’s impurity testing services to verify that the ingredients from their suppliers meet their quality requirements.  Those that have their product produced by third parties frequently use our services to check that their products active ingredients remain present and at the proper levels through batch-to-batch or good vs bad sample testing performed over time.

Don’t risk your product or companies reputation, the presence of an unknown component or impurity can cause not only product performance issues, but can also undermine the safety of your product.  Contaminants can come from many different sources including active ingredients, fillers, reagents, catalysts, solvents, intermediates, excipients, degradation products, and more.  We can determine the source of the impurity and help you develop a resolution.  

Our purity testing laboratory can isolate, characterize, and identify unknown materials and components.  Once the impurity is identified we can determine a method to remove the impurities from your product.  To test for degradants and other product impurities we use a variety of instrumentation and techniques including FT-IR, NMR, AA, LC/MS, GC/MS, ICP-MS and LC/MS.

Avomeen’s Impurity Analysis laboratory can:

  • Test for Component Degradation
    • Preform Forced Degradation Studies
      • Establish Degradation Pathway
  • Impurity Testing in Complex Sample Matrices
  • Identify Residual Solvents & Additives
  • Identify Unknown & Trace Materials
    • Trace Metals
    • Organic Impurities
    • Contamination Analysis
    • USP <231> Heavy Metals
  • Recognize Unreacted Monomers/Oligomers
  • Pharmaceutical Impurities Testing
    • Biopharmacuetical Process Impurities
    • Impurity Testing for New Drug Substances (ICH Q3A(R2))
    • Impurity Testing for New Drug Products (ICH Q3B(R2))
    • API Degradation
    • Non-Active Component Degradation
  • Product Stability Testing
  • Method Development & Validation
    • Genotoxic Impurities
    • Procedure Validation
  • Toxicological Risk Assesment
  • Product Failure Analysis
    • Performance/Efficacy
    • Reduced Shelf Life
    • Strange Odors, Colors and/or Smells
  • Process Impurities
    • Determine Source of Contaminants
  • Extractable & Leachable Testing
    • USP 232/233
      • USP <232> Elemental Impurities – Limits
      • USP <233> Elemental Impurities – Procedures
    • ICH Q3D
    • Analyze Product Containers & Packaging
    • Food Contact Notifications

Whether you need to check for volatile organic impurities, heavy metals, elemental impurities, unknown trace materials or residual solvents, or a range of other contaminants, our GMP purity testing laboratory can identify and quantitate these impurities.  Our full-service laboratory can perform a variety of material testing services including failure analysis, method development and validation, batch-to-batch testing, and extractable/leachable testing services.

For More Information Or A Free Quote, Please Request A Impurities Testing Laboratory Quote Or Call (800) 930-5450 Today.