Nanalysis Scientific Corp. (TSXV: NSCI, OTCQX: NSCIF, FRA: 1N1), a Canadian leader in portable nuclear magnetic resonance (NMR) instruments, has announced a significant advancement in the pharmaceutical industry through its collaboration with the United States Pharmacopeia (USP). A recent study co-published by these two organizations demonstrates the efficacy of benchtop NMR technology for quality control of active pharmaceutical ingredients (APIs).
The pharmaceutical quality control market is valued in the billions, and the introduction of benchtop NMR technology is poised to transform this landscape. Sean Krakiwsky, CEO and Founder of Nanalysis, emphasized the potential of benchtop NMR: “In the not-too-distant future, we expect that benchtop NMR will become an important tool in the multi-billion-dollar market for quality control in the pharmaceutical industry.” Traditional high-field NMR instruments have long been regarded as the gold standard for molecular testing; however, their size and complexity have limited their practical application in many manufacturing environments.
Nanalysis’s benchtop NMR products are designed to provide high-quality data while being compact and user-friendly, making them suitable for various production settings. This innovation is particularly timely as regulatory demands for consistent and safe pharmaceuticals continue to tighten.
The study highlights several advantages of using benchtop NMR technology over traditional methods such as liquid chromatography. Firstly, benchtop NMR enables faster measurements, enhancing productivity in quality control labs. Additionally, it reduces the reliance on harmful solvents, aligning with modern sustainability practices. The technology also simplifies sample preparation, making the process more accessible for users. Furthermore, benchtop NMR operates without the need for calibration, which decreases the requirement for specialized training, and finally, its non-destructive testing capability increases reliability by allowing multiple tests on the same sample without compromising its integrity.
Dr. Susanne D. Riegel, Vice President of Marketing and NMR Product Manager at Nanalysis, noted that the collaboration with USP aims to modernize quality assurance methodologies within the pharmaceutical sector. The introduction of automated analysis methods like USP-ID further lowers barriers to entry for integrating benchtop NMR into pharmaceutical quality control processes.
The partnership between Nanalysis and USP reflects a broader trend toward modernization in pharmaceutical quality assurance. As regulatory agencies increasingly seek innovative solutions to enhance testing methods, Nanalysis aims to submit numerous benchtop NMR methods for USP’s acceptance over the coming years. This initiative is expected to drive growth in quality assurance and control globally.
Nanalysis is also exploring opportunities with other pharmacopeia jurisdictions, including Europe and Japan, to expand its reach and impact in international markets. The company’s commitment to innovation is evident in its ongoing development of advanced hardware and software solutions tailored for diverse industries.
As the pharmaceutical industry continues to evolve, technologies like benchtop NMR are set to play a critical role in ensuring product quality and safety. The collaboration between Nanalysis and USP signifies a pivotal step toward integrating cutting-edge technology into routine pharmaceutical quality control processes, ultimately benefiting manufacturers and consumers alike.
