Compliant method development & testing services

Precise identification of the solid-state forms of materials, such as polymorphs, hydrates, and solvates, is essential for understanding a material’s properties and behaviour. Subtle differences in crystalline structure can have a major impact on a drug’s bioavailability, manufacturability, and stability. On top of that, characterisation methods and results must meet regulatory standards, adhering to Good Manufacturing Practices (GMP) and inspections from regulatory authorities. However, creating and validating new characterisation methods can be complex, expensive, and time-consuming. It requires expertise.

The Eurofins BioPharma Product Testing network of laboratories delivers advanced solid-state characterisation services designed to provide clear, reproducible, and compliant data that supports the development of safe, effective pharmaceutical products. Our expert scientists manage the characterisation process, from sample preparation to analysis, helping you overcome pharmaceutical development challenges in order to meet both your scientific objectives and regulatory obligations. Our teams interpret complex data and help you translate it into actionable insights to make more informed decisions about product development and optimisation.

We support you with method development and testing on raw materials, active pharmaceutical ingredients (API), and pharmaceutical drug products using advanced techniques such as X-ray Powder Diffraction (XRPD) and Solid-State NMR (ssNMR). All services are conducted under GMP requirements, ensuring the highest standards of compliance and reliability. Equipped with state-of-the-art instrumentation, our labs offer high capacity, optimal sensitivity, and rapid turnaround times to support both development and product release.

Services

Solid-state NMR including 19F-NMR capabilities

We are one of few laboratories in the world that can provide ssNMR method development and testing services on ingredients, polymers, and pharmaceutical drug substances and products with 19F-NMR application under GMP guidelines.

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Solutions and Applications

  • Identification and quantitation of polymorphs in APIs
  • Identification and quantitation of polymorphs of APIs in dosage forms (depending on the drug loading)
  • Evaluation of crystalline and amorphous ratio for APIs
  • Spectroscopic confirmation of identity
  • Characterisation of polymers
  • Patent infringement assessment

Equipment

400MHz WB Bruker Avance 

  • Our system is fitted with a dedicated 19F-NMR setup allowing 1H-19F CPMAS experiment
  • 10 positions sample changer
  • Probes: 4mm MAS (1H, 19F, X), 7mm MAS (1H, X)

XRPD characterisation and testing

We provide XRPD (X-ray Powder Diffraction) method development and testing services on raw materials, API and pharmaceutical drug products, under GMP guidelines.

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Solutions and Applications

  • Identification and quantitation of polymorphs in APIs
  • Identification of API in Dosage Forms (depending on the drug loading)
  • Quantitation of crystalline and amorphous ratio for APIs 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
    Equipment

Equipment

Empyrean Panalytical

  • System can measure both transmission and reflection geometry
  • 45 position sample changer
  • Fitted with a TTK (hotstage), which allows variable temperature experiments