NMR Characterization and QC Testing
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
- 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.