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随着对“质量源于设计”理念的深入理解,作为药品生产过程控制技术之一的近红外光谱分析技术由于其独特的优势,已经被越来越多的制药企业所关注和使用。本文介绍了目前收录在各国药典上的近红外分析标准,以及各国制药行业建立的近红外分析方法指导原则,以帮助国内企业更好地理解和应用该技术,同时为药品监管部门制定相应的政策法规提供依据。
Due to its unique advantages, NIR spectroscopy, one of the control technologies of pharmaceutical production process, has been paid more and more attention and application by more and more pharmaceutical companies with its deep understanding of “quality from design” concept. This article presents the near-infrared analysis standards currently included in pharmacopoeias in various countries and guidelines for near-infrared analysis established by the pharmaceutical industry in various countries to help domestic enterprises to better understand and apply the technology and make corresponding policies for drug regulatory authorities Regulations provide the basis.