Impurity Identification and Testing

From residual solvents and process-related impurities to degradant-related impurities, Eurofins Sinensis offers a broad range of services in support of impurities testing for pharmaceutical products and APIs. We are able to identify and quantify very low levels of impurities in the most difficult of sample matrices.

  • 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.
  • For unknown impurity identification, we offer the most 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 provide you with the best strategy for monitoring impurities and accelerating 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 Biomanufacturing
  • Customized method development/validation
    Specific example of methods include:
    • Establishment of methods for residual solvents using either GC or HPLC
    • 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 approaches)
     

Elemental Analysis

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

Instrumentation

Mass Spectrometers

  • Agilent GC/MS
  • Waters Xevo Q-TOF LC-MS
  • Waters Xevo TQ LC-MS/MS
     

Chromatography Equipment

  • Agilent and Shimadzu GCs with either headspace or direct injection sample introduction
  • Waters/Dionex/Thermo Scientific U/HPLCs
  • Waters H-Class UPLCs
  • Waters Classic UPLCs
  • Beckman PA800+ Capillary Electrophoresis (CE)
     

Detectors

  • Evaporative Light Scattering (ELSD)
  • Fluorescence (FL)
  • Flame Ionization Detector (FID)
  • Conductivity
  • Refractive Index (RI)
  • Ultraviolet (UV)
  • Photodiode Array (PDA)
     

Spectrophotometers

  • PE Flame Atomic Absorption Spectrometer
  • PE Hydride Atomic Absorption Spectrometer
  • PE Graphite Furnace Atomic Absorption Spectrometer
     

Contact us to discuss your needs.


Questions? Call us now

+31 (0)71 524 4080