United States
Polymorphism assessment
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.
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.
Solutions and Applications
Equipment
400MHz WB Bruker Avance
We provide XRPD (X-ray Powder Diffraction) method development and testing services on raw materials, API and pharmaceutical drug products, under GMP guidelines.
Solutions and Applications
Equipment
Empyrean Panalytical