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

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

By Yang, Yang; Zhang, Chuntao Pal, Kanjakha Koswara, Andy; Quon, Justin; Mckeown, Rahn; Goss, Charles; Nagy, Zoltan K

View Resource (DOI)

Published on CMKC

09 Jun 2023

Abstract

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.

Journal

Crystal Growth & Design. Volume 16, 12, 2016, 7074–7082

DOI

10.1021/acs.cgd.6b01302

Type of publication

Peer-reviewed journal

Affiliations

Purdue University
GlaxoSmithKline (GSK)
Wuhan University of Science and Technology

Article Classification

Research Article

Classification Areas

Process Control