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

Impurities Testing for Pharmaceutical Products and APIs

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Impurities Testing

Eurofins BioPharma Product Testing offers comprehensive support for impurities testing and contaminant investigations--from residual solvents and process-related impurities to extractables/leachables and degradant related issues. And with complementary expertise in method development, method validation and stability testing, our biopharmaceutical testing team is the perfect partner to provide corrective action follow-up support.

Why Choose Eurofins BioPharma Product Testing?

  • Our scientists are experts at identifying and quantifying very low levels of impurities in the most difficult of sample matrices.
  • We have decades of experience working with active pharmaceutical ingredients and drug product, across all major dosage forms and delivery systems, including unit dose vials (UDVs) and metered dose inhalers (MDIs).
  • 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 cost effective option.
  • We can help determine the most suitable strategies for monitoring impurities and accelerating your drug development programs.
  • Our self-validating method approach for residual solvents testing offers a faster and more cost effective option for those with a short-term or infrequent testing needs.
  • Our 30-year history of cGMP regulatory compliance ensures that you get the highest quality data.

Testing Available

Residual Solvents/Impurities

  • USP <467> and Ph. EUR Method 2.4.24 (all classes of residual solvents in current chapter)
  • 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
  • Leachable methods is 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
  • Applied Biosystems Voyager DE PRO MALDI-TOF
  • Perkin Elmer Inductively Coupled Plasma ICP/MS
  • Thermo Scientific Accela LC/LTQ Orbitrap XL
  • Thermo Scientific TSQ Vantage LC/MS/MS systems with either Agilent 1290 or Thermo Scientific Accela LC’s
  • Waters Xevo G2 LC-MS/TOF
  • Bruker ultrafleXtreme MALDI-TOF/TOF

Chromatography Equipment

  • Agilent GCs with either headspace or direct injection sample introduction
  • Agilent/Waters/Thermo Scientific HPLCs
  • Dionex ICS-3000 Ion Chromatograph (IC)

Detectors

  • Corona Charged Aerosol (CAD+)
  • Electrochemical (ECD)
  • Evaporative Light Scattering (ELSD)
  • Fluorescence (FL)
  • Laser-Induced Fluorescence (LIF)
  • Refractive Index (RI)
  • Ultraviolet (UV)
  • Photodiode Array (PDA)
  • Diode Array (DAD)

Spectrophotometers

  • PE Analyst 800 Flame Atomic Absorption Spectrometer
  • PE Analyst 400 Flame Atomic Absorption Spectrometer
  • PE CHN Analyzer
  • PE Graphite Furnace Atomic Absorption Spectrometer

Contact Us

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