Benchtop NMR for Quality Control

All the versatility and robustness of NMR,
tailored for Pharmaceutical Quality Control

NMR is well known for its unique structural analysis capabilities and its abilities to provide accurate quantitative results without requiring reference standard. These key-features have been used for decades in R&D with high field spectrometer. With the recent availability of benchtop NMR systems such as the Bruker Fourier 80 and new applications based on the minispec TD-NMR,  NMR-based quality control procedures are now even more attractive, specially in the new context of Analytical Quality By Design (AQbD).

NMR-based procedures have indeed gained a significant attention in this new paradigm, as highlighted by the recent revision of ICHQ2 and the on-going revisions of UPS <761> and <1761>. With a unique combination of versatility, universality and robustness, NMR is perfectly tailored for qualitative and quantitative release tests, with a very high level of procedure understanding as required by AQbD. Its capabilities cover the full scope required for release tests, from the simple qualitative identity testing to the more demanding quantitative assays and impurities content determination. Furthermore NMR-based procedure can be tuned for both small and macromolecules, allowing a very large scope of applications, from the pure raw material control to the release test of the drug product. This exceptional versatility combines with significantly simplified procedure life cycle management compared to the more traditional, chromatographic-based technics. Method designs are indeed straightforward since relying on well-known fundamental principles and uncertainty assessment simplified. As an additional benefit, most of the process will be common to all NMR-based methods. This allows platform procedures to be implemented, simplifying all stages of the procedure life cycle, namely design, qualification and continuous verification.

With a reduced footprint, cryogen-free and no-maintenance, the benchtop Fourier 80 NMR spectrometers are perfectly suited to bring the benefices of NMR to QC labs. They allows the straightforward implementation of compendial or in-house qualitative and quantitative procedures. End-to-end automation can be implemented, minimizing the interactions needed by the operator with the system as usually required for routine testing. Full compliance with GLP/GMP regulations is supported by to Bruker unique GxP Solution. Driven with the same software as Bruker high-field NMR systems and based on the same spectrometer than Bruker NMR PAT solutions, the Fourier 80 can thus simply and smoothly bring the benefits of NMR to Pharmaceutical Quality Control.

Access to our latest content on QC using the Fourier 80:


Cassie Yang, Principal Research Scientist at Abbvie

“The Fourier 80 has facilitated the implementation of workflows for controlling the quality of our incoming materials. It offers a simpler and cost-efficient alternative to high-field NMR systems. Combined with the intuitive interface of Mdrive, our non-expert users can directly submit their samples and retrieve their data with ease, while ensuring data integrity. As analysts, our role now only involves validating the final results. With no maintenance requirements, utilizing the Fourier 80 for our quality control applications has thus allowed us to both save time on high-field instruments and reduce the workload of our analytical team. This way, as experts, we can focus on addressing more demanding analytical challenges, while our users independently perform their QC analysis on raw materials.”



Service & Life Cycle Support for Magnetic Resonance and Preclinical Imaging

Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.

LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory