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原材料中颗粒的识别。

Identification of Particles in Raw Materials.

机构信息

, 11 Deer Park Drive, Suite 201, Monmouth Junction New Jersey, 08852, USA.

出版信息

AAPS PharmSciTech. 2018 Jan;19(1):184-191. doi: 10.1208/s12249-017-0823-0. Epub 2017 Jun 23.

Abstract

Raw materials need to be of a certain quality with respect to physical and chemical composition. They also need to have no contaminants in the form of particles because these could get into the product or indicate the raw materials are not pure enough to make a good quality product. When particles are found, it is important to identify their chemical and elemental composition to correct any process errors that can cause them and to have acceptable quality of the final product. Sources of materials can be the environment, process equipment and processing, and packaging. Microscope versions of Raman spectroscopy, laser-induced breakdown spectroscopy (LIBS), and IR spectroscopy are excellent tools for identifying particles in materials because they are fast and accurate techniques needing minimal sample preparation that can provide chemical composition as well as images that can be used for identification. The micro analysis capabilities allow for easy analysis of different portions of samples so that multiple components can be identified and sample preparation can be reduced or eliminated. The complementarity of the techniques provides the advantage of identifying various chemical components, as well as elemental and image analyses. The sources of materials were seen to be the environment, process equipment and processing, and packaging.

摘要

原材料在物理和化学组成方面需要达到一定的质量标准。它们也不能以颗粒的形式含有污染物,因为这些颗粒可能会进入产品中,或者表明原材料不够纯净,无法生产出高质量的产品。当发现颗粒时,确定其化学和元素组成非常重要,这样可以纠正可能导致颗粒产生的任何工艺错误,并确保最终产品具有可接受的质量。原材料的来源可能是环境、工艺设备和加工以及包装。拉曼光谱、激光诱导击穿光谱 (LIBS) 和红外光谱的显微镜版本是识别材料中颗粒的极好工具,因为它们是快速而准确的技术,需要最少的样品制备,可以提供化学成分以及可用于识别的图像。微分析功能允许轻松分析样品的不同部分,从而可以识别多个组件,并减少或消除样品制备。这些技术的互补性具有识别各种化学成分以及元素和图像分析的优势。可以看出,原材料的来源是环境、工艺设备和加工以及包装。

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