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. (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.
Nanalysis Scientific Corp. (OTCQX: NSCIF) ha raggiunto un traguardo importante con il primo test certificato a livello regolatorio per la risonanza magnetica nucleare (NMR) da banco, accettato dalla Farmacopea degli Stati Uniti (USP) e dalla Farmacopea Europea. Il metodo certificato riguarda la determinazione della sostituzione molare nell'Idrossipropil Betadex, un eccipiente fondamentale utilizzato in diversi prodotti farmaceutici.
Questa innovazione consente l'impiego della NMR da banco a 60 MHz per il controllo qualità farmaceutico, segnando una svolta rispetto alle tradizionali tecnologie NMR superconduttive ad alto campo, costose e complesse. L'azienda sta sviluppando ulteriori metodi ufficiali per gli standard ASTM, AOAC e ISO, preparando la NMR da banco per una diffusione su larga scala nell'industria.
Nanalysis Scientific Corp. (OTCQX: NSCIF) ha alcanzado un hito significativo con el primer ensayo certificado regulatoriamente para Resonancia Magnética Nuclear (NMR) de sobremesa, aceptado por la Farmacopea de los Estados Unidos (USP) y la Farmacopea Europea. El método certificado es para la Determinación de Sustitución Molar en Hidroxipropil Betadex, un excipiente importante utilizado en varios productos farmacéuticos.
Este avance permite el uso de la NMR de sobremesa a 60 MHz para el control de calidad farmacéutico, marcando un cambio respecto a la tecnología tradicional de NMR superconductora de campo alto, costosa y compleja. La empresa está desarrollando métodos formales adicionales para las normas ASTM, AOAC e ISO, posicionando la NMR de sobremesa para una adopción industrial generalizada.
Nanalysis Scientific Corp. (OTCQX: NSCIF)는 미국 약전(USP)과 유럽 약전에서 인정받은 최초의 규제 인증 벤치탑 핵자기공명(NMR) 분석법을 달성하는 중요한 이정표를 세웠습니다. 인증된 방법은 다양한 의약품에 사용되는 중요한 부형제인 하이드록시프로필 베타덱스의 몰 치환도 측정에 관한 것입니다.
이 획기적인 성과는 기존의 고가이며 복잡한 초전도 고자장 NMR 기술 대신 60MHz 벤치탑 NMR을 의약품 품질 관리에 활용할 수 있게 하였습니다. 회사는 ASTM, AOAC, ISO 표준을 위한 추가 공식 방법 개발도 적극 진행 중이며, 벤치탑 NMR의 산업 전반에 걸친 광범위한 도입을 준비하고 있습니다.
Nanalysis Scientific Corp. (OTCQX: NSCIF) a franchi une étape importante avec la première méthode d'analyse certifiée réglementairement pour la Résonance Magnétique Nucléaire (RMN) de paillasse, acceptée par la Pharmacopée des États-Unis (USP) et la Pharmacopée Européenne. La méthode certifiée concerne la détermination de la substitution molaire dans l'hydroxypropyl bétadex, un excipient essentiel utilisé dans divers produits pharmaceutiques.
Cette avancée permet l'utilisation de la RMN de paillasse à 60 MHz pour le contrôle qualité pharmaceutique, marquant un tournant par rapport à la technologie traditionnelle coûteuse et complexe de RMN supraconductrice à haut champ. L'entreprise développe activement d'autres méthodes officielles pour les normes ASTM, AOAC et ISO, positionnant ainsi la RMN de paillasse pour une adoption industrielle généralisée.
Nanalysis Scientific Corp. (OTCQX: NSCIF) hat einen bedeutenden Meilenstein erreicht: Der erste regulatorisch zertifizierte Test für Tisch-Nukleare Magnetresonanz (NMR) wurde von der United States Pharmacopeia (USP) und der Europäischen Pharmakopöe anerkannt. Die zertifizierte Methode betrifft die Bestimmung der molaren Substitution in Hydroxypropyl Betadex, einem wichtigen Hilfsstoff in verschiedenen pharmazeutischen Produkten.
Dieser Durchbruch ermöglicht den Einsatz von 60-MHz-Tisch-NMR für die pharmazeutische Qualitätskontrolle und markiert einen Wandel weg von der herkömmlichen, teuren und komplexen supraleitenden Hochfeld-NMR-Technologie. Das Unternehmen entwickelt aktiv weitere formelle Methoden für ASTM-, AOAC- und ISO-Standards und ebnet so den Weg für eine breite industrielle Anwendung der Tisch-NMR.
- 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
- Currently limited to primarily industrial R&D labs and universities
- Still in early stages of widespread industrial adoption
"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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