Identifying and managing impurities

With total confidence

You need clarity on what’s in your product—right down to trace-level impurities. Pharmaceutical products and APIs need low levels of impurities to be determined in the most difficult matrices – this can be an analytical challenge, requiring expertise and state-of-the art equipment. Whether you’re working to accelerate development timelines, address complex matrices, or stay ahead of evolving regulatory requirements, the stakes are high. Impurities can threaten therapeutic efficacy, trigger adverse reactions, or lead to costly compliance failures and delays in product release. That’s why you need a partner with both the scientific depth and analytical capability to uncover and resolve even the most elusive risks.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers world-leading support for the detection, characterisation, and quantification of impurities in pharmaceutical products and APIs. From process and degradation-related organic impurities to inorganic elements and genotoxic impurities, including nitrosamines, we help ensure you meet international requirements, including ICH Q3A, ICH Q3B, ICH Q3D, ICH Q6B, and ICH M7. We assist with determining the most suitable strategies for monitoring impurities and accelerating your drug development programmes or ensure product release.

Our services cover:

  • Nitrosamines/genotoxic impurities
  • PFAS (perfluoroalkyl and polyfluoroalkyl substances) 
  • Elemental impurities/trace metals
  • Residual solvents
  • Extractables & leachables
  • Bioprocess related impurities
  • EO residuals
  • Persistent organic pollutants

We combine state-of-the-art analytical instrumentation with the experience of our highly qualified teamstodetect ultra-low levels of impurities in even the most challenging matrices, using techniques such as HPLC, LC-MS/MS, GC-MS/MS, ICP-MS, and spectroscopic methods.

Our studies are designed to integrate seamlessly into your development lifecycle—whether you’re conducting early-stage assessments, confirming batch release specifications, or responding to regulatory queries. We support method development, validation, and routine testing under GMP conditions.

Testing available

Degradation products

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  • Customised method development/validation
  • Forced degradation studies and assessment of peak purity
  • Finished product and API specific methodology
  • Qualitative/quantitative analysis
  • Tracking/cumulative reporting of stability study data

Elemental analysis

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Qualitative/quantitative limits testing (AA and CHN).

Nitrosamine impurities

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Eurofins offers nitrosamine impurity analysis, as well as support testing for risk assessments.

Peak identification

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Identification of organic compounds using modern mass spectrometry.

PFAS testing

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The screening involves molecule-specific methods. Five PFAS (PFOS, PFOA, PFHxS, PFNA, and HFPO-DA) are already monitored at Eurofins BPT using UHPLC-MS/MS, with 20 additional PFAS expected to be included by 2025. Performance testing is conducted on each matrix, along with PFAS estimation.

Process impurities

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  • Customised method development/validation
  • Finished product and API specific methodology
  • Qualitative/quantitative analysis
  • Tracking/cumulative reporting of stability study data

Residual solvents/impurities

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  • USP <467> and Ph. EUR Method 2.4.24 (all classes of residual solvents in current chapter)
  • Customised method development/validation
  • Extractables/Leachables
  • Validation of disposables for use in biomanufacturing

Trace metals

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Qualitative/Quantitative limits testing (ICP and ICP/MS).

Instrumentation

List of instruments

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Chromatography equipment

  • Agilent GCs with either headspace or direct injection sample introduction
  • Agilent/Waters/Thermo Scientific HPLC/UHPLC
  • Dionex/Thermo Fisher Scientific ICS-5000/+ and ICS-6000/+
  • Thermo Scientific Integrion HPIC

Mass spectrometers

  • Agilent GC/MS and GC/MS/MS
  • Agilent LC/MS-TOF and QTOF
  • Applied Biosystems Voyager DE PRO MALDI-TOF
  • Perkin Elmer Inductively Coupled Plasma ICP/MS
  • Thermo ICP/MS
  • Thermo Scientific Accela LC/LTQ Orbitrap XL
  • Thermo Scientific Vanquish LC/Orbitrap Exploris 120
  • Waters Xevo G2 LC-MS/TOF and LC/MS/MS
  • SCIEX Triple Quad 4500

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, DAD)
  • Conductivity

Spectrophotometers

  • PE Analyst 800 Flame Atomic Absorption
  • PE Analyst 400 Flame Atomic Absorption
  • PE CHN Analyser
  • PE Graphite Furnace Atomic Absorption
  • Thermo iCE3500 Flame/Furnace Atomic Absorption
  • Perkin Elmer PinAAcle 500 Flame Atomic Absorption
  • Perkin Elmer AAnalyst 600 Furnace Atomic Absorption
  • Perkin Elmer PinAAcle 900Z Furnace Atomic Absorption
  • Perkin Elmer ICP/Optical Emission Optima 8300