近红外光谱技术在制药工业中的应用

M. George
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引用次数: 1

摘要

本研究探索了一种近红外光谱分析技术的全面发展,该技术可用于高通量测定药物制剂中的药物原料和辅料。讨论了近红外光谱法作为质量和工艺控制工具的研究进展。应用包括分析不同类型的样品,根据指定的实验设计制造和鉴定活性药物成分。样品在傅里叶变换近红外光谱仪中以扩散或反射模式进行测量。此外,利用化学计量软件对波段进行定量解释。该光谱法可用于原料的粒度、多态性和混合均匀性的鉴别。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Near Infrared Spectroscopy: Applications In Pharmaceutical Industry
This work explores the comprehensive development of a near infrared (NIR) spectroscopic analytical technique for high-throughput applications for the determination of pharmaceutical raw materials and excipients in a pharmaceutical formulation. Advancements in the NIR spectrometry as quality and process control tool have been discussed. The applications include analyses of different types of samples, manufacturing and identification of active pharmaceutical ingredients based on specified experimental design. The samples were measured in diffusion or reflectance mode in a fourier-transform NIR spectrometer. Additionally, chemometric software was employed for quantitative interpretation of bands. The spectrometry can be utilized for identification of raw materials, their size, polymorphism and blend homogeneity.
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