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首页> 外文期刊>American pharmaceutical review >Advanced Approaches to Effective Solid-state Analysis: X-Ray Diffraction, Vibrational Spectroscopy and Solid-state NMR
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Advanced Approaches to Effective Solid-state Analysis: X-Ray Diffraction, Vibrational Spectroscopy and Solid-state NMR

机译:有效固态分析的高级方法:X射线衍射,振动光谱和固态NMR

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摘要

Analysis of the solid state plays a key role in modern drug development during pharmaceutical process development and in support of regulatory filing activities [1-3]. The analytical techniques used in this field span the interface between physical chemistry, materials science, surface science, and supramolecular chemistry, and provide critical knowledge and understanding of complex phenomena such as polymorphism, disorder in the crystalline state, molecular-level interactions in crystalline and amorphous materials, and the formation of defects, inclusions, solid solutions, and related phenomena in materials. The analytical techniques used for these tasks include a variety of physical, thermal, spectroscopic, and diffractometric methods operating upon both bulk and spatially-selective sample presentations [3,4]. The focus of this article is upon the use of spectroscopic or diffratometric methods, which provide some of the most effective and information-rich tools for solid-state analysis. Recent advances in the fields of solid-state spectroscopy and diffraction as applied to pharmaceutical materials, including active pharmaceutical ingredients (APIs) and formulations, have enabled more challenging solid-state analytical questions to be addressed. In particular, advances in vibrational spectroscopy, solid-state NMR (SSNMR), and X-ray diffraction (XRD) are presented and discussed. These advanced methods are often used in a multidisciplinary fashion for the most complex challenges, so that the data from each technique can be co-interpreted to form a more complete picture of the solid state [5].
机译:固态分析在制药工艺开发过程中的现代药物开发中以及在支持法规备案活动中起着关键作用[1-3]。该领域中使用的分析技术涵盖了物理化学,材料科学,表面科学和超分子化学之间的接口,并提供了对复杂现象(例如多态性,结晶态无序,结晶态和结晶态的分子级相互作用)的批判性知识和理解。非晶态材料,以及材料中缺陷,夹杂物,固溶体和相关现象的形成。用于这些任务的分析技术包括对大量和空间选择性样品表现都起作用的各种物理,热,光谱和衍射法[3,4]。本文的重点是光谱或衍射法的使用,它们为固态分析提供了一些最有效且信息最丰富的工具。固态光谱学和衍射领域应用于药物材料(包括活性药物成分(API)和制剂)的最新进展,使得能够解决更具挑战性的固态分析问题。特别是,提出并讨论了振动光谱,固态NMR(SSNMR)和X射线衍射(XRD)方面的进展。这些先进的方法通常以多学科的方式用于最复杂的挑战,因此可以将每种技术的数据共同解释以形成固态的更完整图片[5]。

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