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药物分析中的定量固态核磁共振光谱法(qSSNMR)

Quantitative Solid-State NMR Spectroscopy (qSSNMR) in Pharmaceutical Analysis.

作者信息

Zheng Zhaoxi, Chen Kang, Liu Yang, Munson Eric J, Su Yongchao

机构信息

Department of Chemistry, Brandeis University, Waltham, Massachusetts, USA.

Division of Pharmaceutical Quality Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

Magn Reson Chem. 2025 Jul;63(8):585-592. doi: 10.1002/mrc.5536. Epub 2025 May 26.

Abstract

Pharmaceutical analysis is essential to drug development and quality assurance, ensuring that products meet stringent safety and efficacy standards. Quantitative solid-state NMR (qSSNMR) has become a key technique, enabling precise quantification and characterization of solid drug formulations. This mini-review highlights the evolution of qSSNMR, focusing on improvements in detection limits, resolution, and high-throughput capabilities. This review explores technical advancements and applications for analyzing complex pharmaceutical mixtures. While challenges remain for widespread adoption, efforts in automation, user-friendly software, and collaboration aim to address these.

摘要

药物分析对于药物研发和质量保证至关重要,可确保产品符合严格的安全性和有效性标准。定量固态核磁共振(qSSNMR)已成为一项关键技术,能够对固体药物制剂进行精确的定量和表征。本综述着重介绍了qSSNMR的发展历程,重点关注检测限、分辨率和高通量能力方面的改进。本文探讨了分析复杂药物混合物的技术进步及应用。尽管qSSNMR的广泛应用仍面临挑战,但在自动化、用户友好型软件以及合作方面所做的努力旨在解决这些问题。

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