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Chemical Testing

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Eurofins BioPharma Product Testing Netherlands, fully GMP certified, provide analytical chemical testing solutions for raw materials, drug substances and drug products. Our services range from routine QC testing, such as characterisation, identification and limit tests of compounds, to highly complex methods using combination LC-MS and NMR technologies.   

Routine Testing as per PhEur/USP

The following tests are only a small part of our testing services and  performed routinely on a large scale basis. We offer various additional services surrounding these processes. If you have any questions regarding our services, please do not hesitate to contact us to find out whether we can help.  

Testing Available

  • Complete Compendial Analysis (EP, USP, JP, BP)
  • Residual Solvents
  • Pharmaceutical Water (EP, USP, JP)
  • Elemental Analysis
  • Container Closure Testing (EP, USP)
  • Trace Metals (USP <232> and <233>)

Instrumentation and techniques

A host of instruments and techniques, including but not limited to the list below, is available. Technique not listed? Likely we either still have it or know where to source this to ensure complete analytical coverage.

  • AAS (Flame, Graphite and Hydride)
  • HPLC
  • TGA
  • ICP
  • UPLC (incl MS)
  • DVS
  • Titration
  • CE
  • Microscopy
  • Conductivity
  • TLC
  • ssNMR
  • FT-IR
  • Loss On Drying
  • Water Determination by Karl Fischer (Volumetric & Coulometric)
  • UV-VIS
  • Osmolality
  • X-Ray Powder Diffraction (XRPD)
  • NMR
  • Polarimetry
  • Turbidity
  • GC (incl MS)
  • Viscosity
 
  • TOC
  • DSC
 


Validation of analytical methods per PhEur/USP

Not only can we assist you with routine QC testing, we also offer method development and validation services as per PhEur/USP. A validation project comprises a study protocol, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report.   

Implementation of analytical testing for medical devices and other applications

The enormous range of products and techniques applied in medical devices, each and all with their specific characteristics and requirements, needs to be matched with the appropriate analytical methods to ensure quality and safety. Eurofins Medical Device Testing has been assisting Medical Device customers with their developmental testing and regulatory submissions for over 30 years.

Over four hundred extractable studies are performed annually by our experienced team of scientists, who are also capable to aid you in:

  • Chemical Characterization (ISO 10993-12, 18 and 19)
  • Identification and Quantification of Degradation Products (ISO 10993-13, 14, and 15)
  • Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
  • Residual Ethylene Oxide (ISO 10993-7)
  • Material & Product stability
  • Raw material purity
  • Unaxial mechanical Testing
  • Particle Size

Why choose Eurofins BioPharma Product Testing

  • Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinary organization.
  • Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.

More information about our Medical Device testing capabilities, can also be found at our global Medical Device website.