Solid-state characterization of Raw Material & Drug Product

Eurofins Spinnovation Analytical provides solution for high-end solid-state characterization of raw material and drug products. XRPD and Solid-State NMR methods are available for Analytical R&D projects and
QC testing, both application running under GMP (EU-GMP and FDA inspected).
The scope of our capabilities and expertise are centralized in the Eurofins European Centre of Excellence for NMR and XRPD in Oss, The Netherlands.


Solid-state NMR including 19F-NMR capabilities (GMP)

We deliver you Solid-State NMR (ssNMR) method development and testing services on ingredients, polymers, pharmaceutical drug substances and pharmaceutical drug products, under GMP. Our state-of-the-art equipment allows high capacity, optimum sensitivity and fast turn-around, supporting development and product release. We are a unique laboratory in Europe providing access to GMP-certified ssNMR services.

Equipment

  • 400MHz WB Avance Bruker
  • Our system is fitted with a dedicated 19F-NMR set up allowing 1H-19F CPMAS experiment
  • 10 positions sample changer 
  • Probes: 4mm MAS (1H, 19F, X), 7mm MAS (1H, X)
     

Solutions and Applications

  • Identification and Quantitation of polymorphs in API's
  • Identification and Quantitation of polymorphs of Active Substance in Dosage Forms (depending on the drug loading)
  • Evaluation of Crystalline and Amorphous Ratio for API's
  • Spectroscopic confirmation of Identity
  • Characterization of Polymers
  • Patent infringement assessment

 

XRPD characterization and testing (GMP)

We deliver you XRPD (X-rays Powder Diffraction) method development and testing services on raw materials, pharmaceutical drug substances and pharmaceutical drug products, under GMP. Our state-of-the-art equipment allows for high capacity, optimum sensitivity and fast turn-around, supporting development and release activities.

Equipment

  • Empyrean Panalytical
  • System can measure both transmission and reflection geometry
  • 45 positions sample changer
  • Fitted with a TTK (hotstage) which allows variable temperature experiment
     

Solutions and Applications

  • Identification and Quantitation of polymorphs in API's
  • Identification of Active Substance in Dosage Forms (depending on the drug loading)
  • Quantitation of Crystalline and Amorphous Ratio for API's and Excipients depending on the individual composition
  • Crystallographic confirmation of Identity
  • Rietveld Analysis to refine Atomic Structures and the composition of Multiphase mixtures
  • XRDP phase analysis and Pattern decomposition  
     

Contact our team of specialists for questions and requests about solid-state characterization and testing services: Contact us here.

 


Questions? Call us now

+31 (0)24 240 3400