NMR & EPR PHARMA SOLUTIONS

Benchtop NMR for Quality Control

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

Highlights

Increase Confidence
Absolute method for robust Identification and Assays
Simplify Workflows
Platform procedures for flexibility without comprising compliance
Maximize Efficiency
Contactless technology without instrument preparation for optimal versatility and throughput
Access our Free QC Application Library
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From R&D to Routine Quality Control
NMR is well known for its unique structural analysis capabilities and its abilities to provide accurate quantitative results without requiring reference standards. Traditionally used in research with high-field spectrometers, NMR is now more accessible thanks to benchtop systems like the Bruker Fourier 80. These advancements make NMR-based quality control procedures even more attractive, especially within the modern framework of Analytical Quality by Design (AQbD).

Versatility and Robustness for Modern QC Procedures
NMR-based procedures have gained significant attention with the recent revision of ICH Q2 and the AQbD paradigm implemented by ICH Q14. With a unique combination of versatility and robustness, NMR is perfectly tailored for both qualitative and quantitative release tests. Its capabilities cover a broad spectrum, from simple identity testing to complex quantitative assays and impurity content determination. NMR can be tuned for both small and large molecules, allowing for a wide range of applications, from raw material control to drug product release testing. The commonality among NMR-based methods enables the implementation of platform procedures. It streamlines all stages of procedure life cycles, reducing operational expenses and turnaround times compared to traditional chromatographic techniques

Built-in Compliance for all QC labs
The Bruker Fourier 80 benchtop NMR spectrometer features a compact, cryogen-free design with minimal maintenance, making it ideal for quality control labs. Full compliance with GLP/GMP regulations is supported by GxP Solution. It enables easy implementation of compendial and custom testing procedures and offers an ideal, cost-efficient solution for laboratories to integrate and maximize the benefits of
NMR as a modern technology for QC.

Applications

Webinars

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January 28, 2020

The Application of NMR for Drug Development and Manufacturing in a Good Manufacturing Practice Setting

Good Manufacturing Practice GMP refers to the practices a manufacturer must conform to in order to meet the regulations set by agencies that control a
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January 26, 2021

New Benchtop TD-NMR Solutions for Pharma and BioPharma

Bruker introduces ‘over the counter’ solutions for different pharmaceutical unmet needs such as phase purity, including quantification of low levels of amorphous, 100% fill check of vials and syringes and aggregation determination.
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ON DEMAND SESSION – November 24, 2021

Emerging NMR Solutions for the Pharmaceutical Industry

In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the pharmaceutical industry, aimed at addressing the role of NMR in the development and manufacture of small molecule and biological therapeutics.
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ON DEMAND SESSION - September 1, 2021

NMR in Quality Control and Manufacturing

In this one-hour roundtable, we will discuss the current role of NMR in Quality Control and Manufacturing.
Discovery of small molecules that target RNA. NMR is the method of choice.
ON DEMAND SESSION – June 18, 2024

Validation and implementation of qNMR as platform methods of oligonucleotides and peptides

The content of e.g peptides or oligonucleotides in a sample (solid or liquid) is of importance in many aspects. For peptides traditional methods like Kjeldahl nitrogen determination, elementary analysis (EA), and amino acid analysis (AAA), requires break down of the protein at harsh conditions to determine the protein content. For oligonucleotides one of the most widely used techniques for quantification is ultraviolet (UV) spectroscopy.
Benchtop NMR for streamlined and compliant pharmaceutical Quality Control
ON DEMAND SESSION – September 10, 2024

Benchtop NMR for streamlined and compliant pharmaceutical Quality Control

Analytical Quality by Design in pharma Quality Control places an increase emphasis on analytical procedure understanding. This calls for new approaches on QC procedure management and new technologies such as Nuclear Magnetic Resonance. During this webinar, benefices of implementing NMR for GMP-compliant analytical procedures in QC laboratories using benchtop spectrometers will be discussed and illustrated using qualitative and quantitative case studies.

Testimonials

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.”

Support

LabScape

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