Nanalysis Introduces Benchmarked NMR Assay for Quality Control in Pharmaceuticals

Nanalysis Pioneers Quality Control in Pharmaceuticals with First Regulatory-Approved NMR Assay

Nanalysis Scientific Corp., recognized as a frontrunner in the domain of portable Nuclear Magnetic Resonance (NMR) and MRI technologies, made headlines on July 9, 2025. The company has successfully published an assay for pharmaceutical quality control that has received regulatory certification from both the United States Pharmacopeia (USP) and the European Pharmacopeia (Ph. Euro). This historic advancement is centered on the reliable and effective Molar Substitution Determination in Hydroxypropyl Betadex (USP-NF/Ph. Euro 1804).

Dr. Susanne D. Riegel, VP Marketing and NMR Product Manager at Nanalysis, shed light on the significance of this achievement. Historically, NMR technology, particularly its larger superconducting high-field magnets, has been deemed unsuitable for industrial-quality control due to their complex and costly nature. This has limited the widespread acceptance of NMR in regulatory contexts. However, Dr. Riegel emphasized that by establishing certified methods that utilize the more compact and economical 60 MHz benchtop NMR, they could revolutionize how industries like pharmaceuticals, polymers, and food carry out quality control.

Currently, most of Nanalysis's sales are concentrated in industrial research and development laboratories, as well as universities. The company aims to expand its reach by showcasing how benchtop NMR can efficiently meet the rigorous demands of quality control across multiple sectors. The market potential for hydroxypropyl betadex alone is substantial, given its role as a key excipient in various pharmaceutical products, including vaccines like Jcovden and pain relievers such as paracetamol.

This method's validation with the USP marks a pivotal milestone for Nanalysis, as it allows pharmaceutical manufacturers to confidently utilize benchtop NMR for quality assurance. Sean Krakiwsky, the CEO of Nanalysis, expressed pride in the collaboration with the USP, underscoring their commitment to developing a comprehensive library of formal methods. This library aims to equip industrial and pharmaceutical users with practical options, promoting benchtop NMR as a credible and often optimal solution for quality control practices.

In addition to the methods validated by USP, Nanalysis is also focused on developing standards in alignment with ASTM, AOAC, and ISO methods, further establishing benchtop NMR in various industries. This strategy reflects the company's vision of positioning benchtop NMR as a potent analytical technique, prepared for wide-scale application throughout the industry.

Nanalysis remains dedicated to advancing the capabilities of their NMR technology beyond pharmaceuticals. By catering to sectors such as oil, gas, and chemicals, the organization's innovations offer invaluable contributions to laboratory practices worldwide. As Nanalysis continues to forge partnerships and venture into new markets, the company stands at the forefront of making high-level scientific analysis more accessible and reliable with their compact NMR devices.

The NMReady-60™, which was the first fully functional portable NMR spectrometer requiring no liquid helium or other cryogens, exemplifies Nanalysis's commitment to innovation. This pioneering device has laid the groundwork for subsequent advancements, culminating in their latest 100 MHz technology—the most powerful compact NMR system available in the commercial market.

With a robust plan for submissions aiming at modernizing various key assays for the pharmaceutical industry, Nanalysis is committed to broadening the implementation of their technology. This initiative responds to the growing demand for efficient, cost-effective solutions in quality control, offering an inclusive approach to both established manufacturers and emerging players in the pharmaceutical landscape.

As industries evolve, the introduction of the certified assay represents not only a technical achievement but a transformative opportunity for the future of quality assurance in pharmaceuticals. The collaboration with USP signals a new era for benchtop NMR. Nanalysis is set to expand its impact, making their technology a cornerstone of quality control across diverse sectors.