Mr. Sean Krakiwsky reports

NANALYSIS ANNOUNCES FIRST REGULATED ASSAY FOR PHARMACEUTICAL QUALITY CONTROL VIA BENCHTOP NMR ACCEPTED BY THE UNITED STATES PHARMACOPEIA (USP) AND EUROPEAN PHARMACOPEIA (PH. EURO)

Nanalysis Scientific Corp. has noted the publication in the National Formulary of the first regulatory certified assay for bench-top NMR -- the Molar Substitution Determination in Hydroxypropyl Betadex USP-NF/Ph. Euro (1804).

"Currently Nanalysis sells primarily into industrial R&D labs and universities, but to more ubiquitously proliferate the use of bench-top 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 vice-president of marketing and NMR product manager. "Having certified regulatory methods that specifically use 60 MHz bench-top NMR for approved assays is an initial and important step for larger-scale global deployment of bench-top 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's application team worked with the USP to validate this hydroxypropyl betadex method and modernize it to certify the use of 60-megahertz data to ensure product quality.

Sean Krakiwsky, Nanalysis chief executive officer, states: "We are proud of our relationship with the USP, and we are committed to submitting a full library of formal methods to USP, so that industrial and pharma users can be confident that bench-top 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 bench-top NMR narrative, as it becomes the latest critical analytical technique to be miniaturized and begin widespread adoption in industry."

About Nanalysis Scientific Corp.

Nanalysis Scientific 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 100 MHz 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, flavour 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, $160-million contract to provide maintenance services for passenger screening equipment in Canadian airports. This has resulted in expansion of the company's security services business. The company is providing airport security equipment maintenance services in each province and territory of Canada. In addition, the company provides commercial security equipment installation and maintenance services to a variety of customers in North America.

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