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A nondestructive and noninvasive method to determine water content in lyophilized proteins using low‐field time‐domain NMR
Author(s) -
Abraham Anuji,
Elkassabany Omar,
Krause Mary E.,
Ott Andrew
Publication year - 2019
Publication title -
magnetic resonance in chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.483
H-Index - 72
eISSN - 1097-458X
pISSN - 0749-1581
DOI - 10.1002/mrc.4864
Subject(s) - chemistry , freeze drying , water content , moisture , chromatography , geotechnical engineering , organic chemistry , engineering
Determining the moisture content in lyophilized solids is a fundamental step towards predicting the quality and stability of lyophilized products, but conventional methods are time‐consuming, invasive, and destructive. High levels of residual moisture in a lyophilized product can lead to cake collapse, product degradation, and reduced shelf life. The aim of this study was to develop a fast, noninvasive, nondestructive, and inexpensive method for determining the moisture content in a lyophilized monoclonal antibody (mAb) formulation using benchtop low‐field time‐domain nuclear magnetic resonance spectroscopy.