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 Characterisation in Oss, The Netherlands. We offer several testing methods for analytical R&D project and QC testing:
Solid-State NMR analysis
One integrated Eurofins BPT Centre of Excellence provides centralised NMR testing capabilities and knowledge all in one facility. We deliver you Solid-State NMR (ssNMR) method development and QC testing services on ingredients, polymers, pharmaceutical drug substances and pharmaceutical drug products, under cGMP guidelines. 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 testing services.
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)
- Instruments are cGMP compliant and FDA inspected
Solutions and Applications
- NMR Solid-state characterisation: 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
XRD/XRPD testing and characterisation
We deliver you XRD/XRPD 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
- XRPD phase analysis and Pattern decomposition
Particle Size Distribution (PSD) analysis - 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 BV, we have a Malvern Mastersizer, using the wet dispersion technique, to perform PSD testing.
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)
Why choose Eurofins BioPharma Product Testing Netherlands?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of GMP product testing laboratories, we can offer a comprehensive testing service portfolio to our customers.
- Standard and custom solutions. If our standard methods do not meet your needs, our skilled technicians can develop customised testing methods tailored to your specific requirements.
Contact our team of specialists for questions and requests about solid-state characterisation and testing services.
