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BioPharma Product Testing NL >> Services >> Release Testing

Release Testing

Eurofins BioPharma Product Testing Netherlands offers the capacity and breadth of capabilities to test your Drug Product or Drug Substance in a timely manner. We test materials against specification for identity, impurities, physical properties and safety under strict cGMP compliance, and we customize individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible.

Our services range from routine QC testing, such as characterization, identification and limit tests of compounds, to highly complex methods using combination LC-MS and NMR technologies.

Release testing services are performed routinely and on a large scale basis for both Finished Dosage Forms (FDF) as Raw Materials such as Active Pharmaceutical Ingredients or Excipients. Surrounding these processes, we also offer various additional services. If you have any questions regarding our services, please do not hesitate to contact us to find out whether we can help.

 

Available Testing

  • Compendial testing according to EP, USP, JP, BP
  • Identity testing
  • Biosafety testing
  • Elemental analysis
  • Container Closure Testing (EP, USP, and deterministic methods like HVLD)
  • Potency testing

 

Instrumentation

  • AA, GFAA
  • Titration
  • Conductivity
  • Fourier Transform-Infrared Spectroscopy
  • GC
  • HPLC
  • ICP/OES
  • Loss On Drying
  • Osmometry
  • Polarimetry
  • TLC
  • TOC
  • Turbidity
  • UV Spectroscopy
  • Viscosity
  • Water Determination by Karl Fischer (Volumetric & Coulometric)
  • X-Ray Powder Diffraction (XRPD)
  • Microscopy
  • PSD
  • ICP-MS

Click here to see our full equipment list.

 

Validation of analytical methods

Not only can we assist you with QC Release testing, we also offer method development, verification and validation services. A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report.

 

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.
  • Standard & 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.