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NIR Spectroscopy Analysis of Phosphate Salts: Qualitative Identification and Quantitative Contamination

机译:磷酸盐的近红外光谱分析:定性鉴定和定量污染

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摘要

Conflrmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex,time-consuming, and laborious protocols. A common test procedure that is considerably easier and quicker to perform than laboratory chemical tests involves near-infrared (NIR) spectroscopy.
机译:保证原材料质量是生物制药生产过程的重要组成部分。不正确或质量差的供应商材料占失败和召回产品的很大一部分。为了避免这些昂贵的问题,通常会实施严格的质量控制(QC)程序,并将其用于筛选不适当的进料。常用的QC程序是化学测试,涉及将样品移至实验室并进行,这有时可能是复杂,耗时且费力的操作。比实验室化学测试更容易,更快捷地执行的通用测试程序包括近红外(NIR)光谱。

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