Benchtop NMR for 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.

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