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NMR Characterization and QC Testing

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Eurofins BioPharma Product Testing Netherlands provides NMR characterization and QC-testing solutions for raw materials, drug substances and drug products.

Eurofins Centre of Excellence for NMR

We deliver you Solution- and Solid-State NMR (ssNMR) contract research and method development services. We support projects and testing related to ingredients, polymers, pharmaceutical drug substances and pharmaceutical drug products. Our state-of-the-art equipment allows for high capacity, optimum sensitivity and fast turn-around, supporting development and product release. One integrated Eurofins BPT Centre of Excellence provides centralized NMR capabilities and knowledge.

GMP NMR testing

Services are performed under cGMP guidelines (EU/USFDA GMP compliant). A broad scope of NMR QC-testing services for raw materials and pharmaceutical products is available. Solutions from execution of compendial NMR methods to custom development and validation.

Solutions and Applications

  • Solid-state characterization: crystal polymorphism, solid-state process development, impurity ID, limit test, etc.
  • Identification of unknown (impurity identification, metabolite identification)
  • qNMR for quantitative release assay
  • Qualification of references for identity
  • High throughput QC of compound library
  • Range of Pharmacopoeial methods (EP / USP) available: Heparin (sodium/calcium/LMWH); Poloxamer; Enoxaparin; Polyoxyl; Hydroxypropyl; Chitosan; Oxytocin; Goserelin; and many more
  • Transfer of client methods or custom development and validation

Equipment

  • 2 x 500MHz NMR Bruker Avance III, BBFO probe and TCI cryopobe, SampleJet
  • 400MHz NMR Bruker Avance III, BBFO probe (1H, 13C, 31P, 19F), SampleJet
  • 400MHz WB Bruker Avance fitted with a dedicated 19F-NMR set up allowing 1H 19F CPMAS experiments, 10 positions sample changer , Probes: 4mm MAS (1H,19F, X), 7mm MAS (1H, X)
  • LC-SPE/NMR capability
  • Instruments are cGMP compliant and FDA inspected

Contact our team of specialists for questions and requests about NMR characterization and testing services.