Release Testing >> Raw Materials - API and excipients >> Solid-state characterization of Raw Material & Drug Product

Solid-state characterization of Raw Material & Drug Product

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Eurofins BioPharma Product Testing Netherlands provides solution for high-end solid-state characterization of raw material and drug products. XRPD, Solid-State NMR, DSC, TGA and DVS methods are available for Analytical R&D projects and QC testing, Applications are running under GMP (EU-GMP and FDA inspected). The scope of our capabilities and expertise are centralized in the Eurofins Centre of Excellence for NMR and Solid-State Characterization 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 for high capacity, optimum sensitivity and fast turn-around, supporting development and product release. We are a leading 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, validation and testing services on raw materials, 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  

Particle size - Laser Light Diffraction

Particle size is measured by the dispersion and absorption of light (red and blue) generated by a laser using either the wet or dry dispersion techniques. At Eurofins Spinnovation Analytical, we have a Malvern Mastersizer, using the wet dispersion technique.

Volume requirements: from 0.1 g – 10 g per sample determination for wet dispersion.
Particle sizes: 10 nm –1500 μm for wet dispersion with Hydro MV, and 10 nm –200 μm for wet dispersion with Hydro SV.
Instrumentation: Malvern Mastersizer 3000 with medium volume Hydro MV automated liquid sample dispersion unit (120mL), or with small volume Hydro SV automated liquid sample dispersion unit (6mL)

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