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Nanalysis Announces First Regulated Assay for Pharmaceutical Quality Control via Benchtop NMR Accepted by the United States Pharmacopeia (USP) and European Pharmacopeia (Ph. Euro)
Prnewswire· 2025-07-09 12:30
Core Insights - Nanalysis Scientific Corp. has published the first regulatory certified assay for benchtop NMR in the National Formulary, specifically for Molar Substitution Determination in Hydroxypropyl Betadex USP-NF/Ph. Euro [1] - The company aims to expand the use of benchtop NMR in industrial quality control across various sectors, including pharmaceuticals and food, by developing gold standard methods accepted by regulatory authorities [2][3] - Nanalysis is committed to submitting a comprehensive library of formal methods to the USP, enhancing the credibility of benchtop NMR as a viable option for quality control [3] Company Overview - Nanalysis operates primarily in two segments: Scientific Equipment and Security Services, focusing on portable NMR instruments for industrial and research applications [4][5] - The NMReady-60™ is highlighted as the first full-feature portable NMR spectrometer that does not require liquid helium, showcasing the company's innovation in compact NMR technology [4] - The company has expanded its Security Services business through a five-year, $160 million contract for maintenance services of passenger screening equipment in Canadian airports [6] Market and Applications - Nanalysis's devices are utilized across multiple industries, including oil and gas, pharmaceuticals, and law enforcement, indicating a broad market presence [5] - The hydroxypropyl betadex market is identified as a billion-dollar opportunity, with plans for additional excipient method submissions to enhance product quality in pharmaceuticals [2]