Changeflow GovPing Pharma & Drug Safety USP Granted Patent for Automated NMR System
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USP Granted Patent for Automated NMR System

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Published March 12th, 2026
Detected March 28th, 2026
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Summary

The U.S. Pharmacopeia (USP) has been granted a patent by the United States Patent and Trademark Office for an automated nuclear magnetic resonance (NMR) system. This patented approach aims to make NMR technology more reliable and easier to use by automating spectral processing and comparison to USP reference standards.

What changed

The U.S. Pharmacopeia (USP) announced it has been granted U.S. patent 12,571,867 for an automated nuclear magnetic resonance (NMR) system. This system processes NMR spectra, compares them to quantum mechanical spectral analysis (QMSA) models tied to USP reference standards, and identifies/quantifies compounds and impurities. This technology is utilized in USP's NMR analysis software, USP-ID, to enhance the accessibility and consistency of quality standards in digital workflows.

This development offers a new way to make reference standards more accessible and reliable for scientists and laboratories. By enabling QM-based digital reference standards for NMR, USP aims to reduce analyst variability, improve consistency, and support the adoption of digital workflows in drug development and manufacturing. While this is a patent grant and not a direct regulatory mandate, it signifies USP's innovation in supporting quality standards within the pharmaceutical industry.

Source document (simplified)

USP granted patent for automated nuclear magnetic resonance (NMR) system

The patented approach makes NMR technology more reliable and easier to use across different laboratories.

ROCKVILLE, MD, March 12, 2026 – The U.S. Pharmacopeia (USP) has been granted U.S. patent 12,571,867 by the United States Patent and Trademark Office.

The patent, titled "Nuclear magnetic resonance analysis systems and methods”, covers an NMR-based system that automatically processes an NMR spectrum, compares it to quantum mechanical spectral analysis (QMSA) models that are tied to USP reference standards, and then identifies and quantifies one or more compounds and impurities.

USP-ID, an NMR analysis software solution that identifies, quantifies, and labels chemical components in simple solutions and complex mixtures, uses this proprietary system to automatically identify and quantify compounds and impurities using models linked to USP standards.

“This patent recognizes a new way to make reference standards more accessible to the scientists and laboratories who rely on them every day,” said Ben Shapiro, Head of Digital Standards at USP. “By enabling QM-based digital reference standards for NMR, we can expand access to trusted standards without the traditional barriers of physical materials, helping more people apply consistent, high-quality science natively in the digital systems where they work.”

Traditional NMR workflows rely on manual interpretation or simple spectral overlays. The patented system uses QMSA models and automation routines that can help reduce analyst variability and create consistent, traceable identification and impurity assessment analyses. This approach helps NMR spectroscopists to integrate quality standards into quickly deployable digital workflows with greater efficiency, consistency, and reduced risk.

The transformation to digital workflows requires new solutions, including methods, reference materials, and standard operating practices, that can support quality throughout drug development and manufacturing.

To learn more about how USP supports digital transformation in pharmaceutical manufacturing, visit: https://www.usp.org/digital-standards.

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About USP

USP is a private scientific organization that collaborates with scientific experts and global stakeholders to develop science-based standards and solutions that help strengthen regulatory systems, simplify complex manufacturing supply chains, enhance supply reliability, and support adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in helping increase the availability of quality medicines, supplements and food ingredients for billions of people worldwide.

Media Contact: mediarelations@usp.org

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
USP
Published
March 12th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
U.S. patent 12,571,867

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Development Quality Control
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Research & Development
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Intellectual Property Technology

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