Characterization of Biologics >> Physico-chemical and Biochemical characterization >> Impurities

Impurities

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Impurity Identification and Testing

From residual solvents and process-related impurities to degradant-related impurities, Eurofins BioPharma Product Testing Netherlands offers a broad range of services in support of impurity testing for raw materials, biological products, and APIs. We are able to identify and quantify low levels of impurities in the most difficult of sample matrices.

  • For unknown impurity identification, we offer an extensive range of mass spectrometric approaches, including accurate mass.
  • Our history of cGMP regulatory compliance ensures that you get the highest quality data.
  • With extensive expertise in developing, validating and providing testing support for impurities, we can equip you with the best strategy for monitoring impurities and to accelerate your drug development programs.

Testing Available

Residual Solvents/Impurities

  • USP <467> (all classes of residual solvents in current chapter)
  • Customized method development/validation
  • Validation of disposables for use in Bio-manufacturing
  • Customized method development/validation

Process Related Impurities

  • Customized method development/validation
  • Product and API specific methodology
  • Glycan analysis
  • Related compounds
  • Tracking/trending of resulting stability studies
  • Microbiological purity testing

Degradation Products

Trace Metals

  • Qualitative/Quantitative limit testing (using ICP approaches)

Contact us to discuss your needs.