Impact of Sample Preparation on Residual Moisture Analyses for a Lyophilized Protein Formulation

被引：0
|
作者：
S. Ottoboni
D. Wong
E. Pungor
机构：
[1] Berlex Biosciences,Process Development
来源：
Journal of Thermal Analysis and Calorimetry | 1998年 / 51卷
关键词：
Karl Fischer; lyophilized; relative humidity; residual water; sorption/desorption; thermogravimetric analysis;
D O I：
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学科分类号：
摘要：
This study compares residual moisture data obtained by thermogravimetric (TG) and Karl Fischer (KF) analyses of freeze-dried recombinant Desmodus rotundus salivary plasminogen activator (DSPA) and the protein free placebo. Significant changes in water content were observed depending on the sample type as well as the relative humidity of the exposure environment prior to analysis. The TG and KF analyses gave identical results only when the samples were handled identically. The method of choice for the determination of the true total moisture content of these samples is the KF analysis since it can be performed without any opportunity for water exchange with the environment.
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页码：339 / 347
页数：8
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