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Updated: Jul 24, 2025

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

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定量NMR在药物分析中的应用:在临床研究的早期阶段,对两种新化学实体的方法合格和强度确定

Xun Guo1, William Miller1, Maryam Zangi2

  • 1Analytical Development, Biogen Inc., Cambridge, MA 02142, United States.

Journal of pharmaceutical and biomedical analysis
|July 8, 2023
PubMed
概括

定量NMR (qNMR) 提供了一种可持续且高效的方法来确定新化学实体的强度. 这种分析技术提供了准确和精确的结果,在药物测试中表现优于传统的基于LC的方法.

关键词:
早期临床新化学实体的临床新化学实体.方法开发方法的开发方法.方法资格认证 方法资格认证强度的确定强度的确定.可持续发展 可持续性 可持续性在QNMR中,QNMR是指QNMR.

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Nuclear magnetic resonance (NMR) spectroscopy is a very valuable analytical technique for researchers. It has been used for more than 50 years as an analytical tool. F. Bloch and E. Purcell formulated NMR in 1946 and won the 1952 Nobel Prize in Physics  for their work. Biological macromolecules such as proteins, nucleic acids, lipids, and organic molecules including pharmaceutical compounds, can be studied using this versatile tool that exploits the magnetic properties of certain nuclei.
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Quantitative analysis is a technique for measuring the amount of specific constituents in a sample. When the sample's composition is unknown, qualitative analysis is performed first to identify its components, which ensures that the correct substances are measured during the quantitative phase.
In quantitative analysis, two key measurements are made: the sample quantity and a property proportional to the amount of the analyte (the substance being analyzed). This forms the basis of the...
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Qualitative Analysis01:10

Qualitative Analysis

Qualitative analysis is the process of identifying elements, ions, or compounds in an unknown sample. It is the first and most fundamental type of analysis based on the hierarchy of analytical goals. This hierarchy is significant as it provides a structured approach to scientific research, with qualitative analysis serving as the initial step, providing essential information before moving on to quantitative or other forms of analysis.
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¹H NMR Signal Integration: Overview

The intensity of a signal, which can be represented by the area under the peak, depends on the number of protons contributing to that signal. The area under each peak is shown as a vertical line called an integral, with the integral value listed under it, as seen in the proton NMR spectrum of benzyl acetate. Each integral value is divided by the smallest integral value to obtain the ratio of the number of protons producing each signal. The ratio reveals the relative number of protons and not...
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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