Bio/Pharma Product Testing Services >> Method Development >> Impurities Testing

Impurities Testing for Pharmaceutical Products and APIs

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From residual solvents and process-related impurities to extractables/leachables and degradant-related impurities, Eurofins BioPharma Product Testing offers a broad range of services in support of impurities testing. We are able to identify and quantify very low levels of impurities in the most difficult of sample matrices.

Why Choose Eurofins BioPharma Product Testing?

  • If you have a short-term or infrequent need for  testing, our self-validating method approach for  residual solvents testing is a faster and more costeffective  option.
  • For unknown impurity identification, we offer the  most extensive range of mass spectrometric approaches,  including accurate mass.
  • Our 30-year 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 provide  you with the best strategy for monitoring impurities and  accelerating your drug development programs.

Testing Available

Residual Solvents/Impurities

  • USP <467> and Ph. EUR Method 2.4.24 (all classes of residual solvents in current chapters)
  • Customized method development/validation
  • Extractables/Leachables
    • Controlled extraction studies
    • Simulation studies
    • Leachable method development, validation & monitoring
  • Validation of disposables for use in Biomanufacturing
  • Customized method development/validation

Specific example of methods include:

  • Establishment of methods for residual solvents using either GC or HPLC
  • Leaachable methods in process intermediates or final formulations
  • Trace metals by Inductively Coupled Plasma in drug products

Process Impurities

  • Customized method development/validation
  • HPLC product and API specific methodology
  • Qualitative/Quantitative analysis
  • Tracking/trending of resulting stability studies

Degradation Products

  • Customized method development/validation
  • Forced degradation studies and assessment of  peak purity
  • Finished product and API specific methodology
  • Qualitative/Quantitative analysis
  • Tracking/trending of resulting stability studies

Trace Metals

  • Qualitative/Quantitative limits testing (using ICP and ICP/MS approaches)

Elemental Analysis

  • Qualitative/Quantitative limits testing (using AA and CHN approaches)

Instrumentation

Mass Spectrometers

  • Agilent GC/MS
  • Agilent LC/MS-Iontrap
  • Agilent LC/MS-TOF
  • Perkin Elmer Inductively Coupled Plasma ICP/MS

Chromatography Equipment

  • Agilent GCs with either headspace or direct injection
  • sample introduction
  • Agilent/Waters/Thermo Scientific HPLCs
  • Dionex ICS-1000 Ion Chromatograph (IC)

Detectors

  • Evaporative Light Scattering (ELSD)
  • Fluorescence (FL)
  • Refractive Index (RI)
  • Ultraviolet (UV)
  • Diode Array (DAD)

Spectrophotometers

  • PE Analyst 400 Flame Atomic Absorption  Spectrometer
  • PE Graphite Furnace Atomic Absorption  Spectrometer