Nanalysis Announces First Regulated Assay for Pharmaceutical Quality Control via Benchtop NMR Accepted by the United States Pharmacopeia (USP) and European Pharmacopeia (Ph. Euro)
Rhea-AI Summary
Nanalysis Scientific Corp. (OTCQX: NSCIF) has achieved a significant milestone with the first regulatory certified assay for benchtop Nuclear Magnetic Resonance (NMR) being accepted by the United States Pharmacopeia (USP) and European Pharmacopeia. The certified method is for Molar Substitution Determination in Hydroxypropyl Betadex, an important excipient used in various pharmaceutical products.
This breakthrough enables the use of 60 MHz benchtop NMR for pharmaceutical quality control, marking a shift from traditional expensive and complex superconducting high-field NMR technology. The company is actively developing additional formal methods for ASTM, AOAC, and ISO standards, positioning benchtop NMR for widespread industrial adoption.
Positive
- First regulatory certified assay for benchtop NMR accepted by USP and European Pharmacopeia
- Opens up new market opportunities in pharmaceutical quality control
- Validates benchtop NMR as viable alternative to expensive traditional NMR technology
- Targets billion-dollar global hydroxypropyl betadex market
Negative
- Currently limited to primarily industrial R&D labs and universities
- Still in early stages of widespread industrial adoption
News Market Reaction – NSCIF
On the day this news was published, NSCIF gained 1.21%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
"Currently Nanalysis sells primarily into industrial R&D labs and universities, but to more ubiquitously proliferate the use of benchtop NMR and drive higher sales growth, one of our strategic targets has been the development of gold standard methods for industrial quality control (QC) in pharma, polymers, chemical, food and other sectors. To accomplish this, NMR must become an accepted technique for regulatory authorities such as USP. Until recently, this has not happened because traditional large superconducting high-field NMR magnet technology has been excluded from industrial QC because of its complexity, cost, and safety issues which has rendered it economically unviable," said Dr. Susanne D. Riegel, Nanalysis VP Marketing & NMR Product Manager. "Having certified regulatory methods that specifically use 60 MHz benchtop NMR for approved assays is an initial and important step for larger scale global deployment of benchtop NMR for industrial QC."
Nanalysis has been working with thought leaders for many years from within industry and regulatory bodies to identify key assays for polymers and pharmaceuticals that would benefit from modernization, and possibly digitalization. With a global billion-dollar market, hydroxypropyl betadex, was a clear, early target, and there will be more excipient method submissions, as the Company adds to the repository of formal methods. Excipients are the drug the delivery mechanisms for active pharmaceuticals and ensure medicine stability. They are used in a wide range of pharmaceutical products, such as vaccines including Jcovden, painkillers like paracetamol, and disease treatment medications like Gilenya. Nanalysis' application team worked with the USP to validate this hydroxypropyl betadex method and modernize it to certify the use of 60 MHz data to ensure product quality.
Sean Krakiwsky, Nanalysis CEO, states, "We are proud of our relationship with the USP (https://www.usp.org), and we are committed to submitting a full library of formal methods to USP, so that industrial and pharma users can be confident that benchtop NMR is a viable option and in many cases the best option for QC. The USP has an important portfolio of offerings to support industry, including the USP-ID software packages as well as their reputation as the global leader in testing standards for pharma. In addition to the USP methods, Nanalysis is also developing formal ASTM, AOAC, and ISO methods and standards for industrial users. We believe we are in the early innings of the benchtop NMR narrative, as it becomes the latest critical analytical technique to be miniaturized and begin widespread adoption in industry."
Click on this link: https://www.nanalysis.com/usp-nf-hydroxypropyl-betadex
About Nanalysis Scientific Corp. (TSXV: NSCI, OTCQX: NSCIF, FRA:1N1)
Nanalysis Scientific Corp. in operates two primary business segments: Scientific Equipment and Security Services. Within its Scientific Equipment business is what the Company terms "MRI and NMR for industry." The Company develops and manufactures portable Nuclear Magnetic Resonance (NMR) spectrometers or analyzers for laboratory and industrial markets. The NMReady-60™ was the first full-feature portable NMR spectrometer in a single compact enclosure requiring no liquid helium or any other cryogens. The Company has followed-up that initial offering with new products and continues to have a strong innovation pipeline. In 2020, the Company announced the launch of its 100MHz device, the most powerful and most advanced commercial compact NMR device ever brought to market.
The Company's devices are used in many industries (oil and gas, chemical, mining, pharma, biotech, flavor and fragrances, agrochemicals, law enforcement, and more) as well as numerous government and university research labs around the world. The Company is working to expand into new global market opportunities independently and with partners. With its partners, the Company provides scientific equipment sales and maintenance services globally.
In 2022 the Company was awarded a five-year,
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SOURCE Nanalysis Scientific Corp.
FAQ
What regulatory milestone did Nanalysis Scientific (NSCIF) achieve in July 2025?
How does Nanalysis's 60 MHz benchtop NMR technology differ from traditional NMR systems?
What is the market potential for Nanalysis's certified NMR method?
What are Nanalysis's future plans for regulatory certifications?
Where is Nanalysis's benchtop NMR technology currently being used?
