Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization

Yang Yang; Zhang Chuntao; Pal Kanjakha; Koswara Andy; Quon Justin; McKeown Rahn; Goss Charles; Nagy Zoltan K.

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Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization

机译：超高效液相色谱作为在线过程分析技术工具在药物结晶中的应用

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Concentration is often an important process parameter in pharmaceutical crystallization processes. In this work, an ultra-performance liquid chromatography (UPLC) system designed for process monitoring (Waters PATROL UPLC) was applied online as a process analytical technology tool for real-time multicomponent concentration monitoring in pharmaceutical crystallization. Three online UPLC-based applications were investigated: (1) solute concentration monitoring during crystallizations and associated solubility, dissolution, and degradation analyses, (2) quick calibration for UV/vis and Raman spectroscopy, and (3) real-time crystallization product purity monitoring.

机译：在药物结晶过程中，浓度通常是重要的过程参数。在这项工作中，专为过程监控设计的超高性能液相色谱（UPLC）系统（Waters PATROL UPLC）在线用作过程分析技术工具，用于实时监测药物结晶中的多组分浓度。研究了三个基于UPLC的在线应用程序：（1）结晶过程中的溶质浓度监控以及相关的溶解度，溶解和降解分析，（2）UV / vis和拉曼光谱的快速校准，以及（3）实时结晶产物的纯度监控。

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《Crystal growth & design》 |2016年第12期|共9页
作者
Yang Yang; Zhang Chuntao; Pal Kanjakha; Koswara Andy; Quon Justin; McKeown Rahn; Goss Charles; Nagy Zoltan K.;
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正文语种 eng
中图分类晶体学;
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1. Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization [J] . Yang Yang, Zhang Chuntao, Pal Kanjakha, Crystal growth & design . 2016,第12期

机译：超高效液相色谱作为在线过程分析技术工具在药物结晶中的应用
2. Large Scale Demonstration of a Process Analytical Technology Application in Bioprocessing: Use of On-line High Performance Liquid Chromatography for Making Real Time Pooling Decisions for Process Chromatography [J] . Anurag S. Rathore, Lilly Parr, Shinta Dermawan Biotechnology Progress . 2010,第2期

机译：大规模演示过程分析技术在生物处理中的应用：使用在线高效液相色谱法为过程色谱法做出实时合并决策
3. Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on-line high-performance liquid chromatography (HPLC) for making real-time pooling decisions for process chromatography [J] . Rathore AS, Yu M, Yeboah S, Biotechnology and Bioengineering . 2008,第2期

机译：案例研究和过程分析技术（PAT）在生物处理中的应用：在线高效液相色谱（HPLC）用于为过程色谱做出实时合并决策
4. Characterizing periodic flow crystallization of a pharmaceutical drug using integrated process analytical technologies (PAT) [C] . K.A. Powell, A.N. Saleemi, C.D. Rielly, International Symposium on Industrial Crystallization . 2014

机译：使用综合工艺分析技术表征药物的周期性流动结晶（PAT）
5. Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes. [D] . Nalbandyan, Lilit. 2014

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6. Processing Technology Investigation of Loquat (Eriobotrya japonica) Leaf by Ultra-Performance Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometry Combined with Chemometrics [O] . Labin Wu, Xue Jiang, Linfang Huang, -1

机译：高效液相色谱-四极杆飞行时间质谱结合化学计量学研究Investigation叶的加工工艺
7. Determination Methods for Biologically Active Compounds by Ultra-Performance Liquid Chromatography Coupled with Mass Spectrometry: Application to the Analyses of Pharmaceuticals, Foods, Plants, Environments, Metabonomics, and Metabolomics [O] . T. Toyooka 2008

机译：通过超级液相色谱法与质谱相偶联的生物活性化合物的测定方法：应用于药物，食品，植物，环境，代谢族和代谢组学的分析

Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization

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