TG/MS capillary interfaceApplications to determination of residual moisture in BCG vaccine and other freeze-dried biological products

被引：0
|
作者：
J. C. May
A. V. Del Grosso
R. M. Wheeler
N. M. Etz
机构：
[1] Center for Biologics Evaluation and Research,
[2] Food and Drug Administration,undefined
来源：
Journal of thermal analysis | 1997年 / 49卷
关键词：
lyophilization; residual moisture; TG/MS interface;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
A TA Instruments Thermal Analysis System (TG) has been interfaced to the Hewlett Packard 5972 quadrupole mass spectrometer. An OSS-2 variable outlet splitter was plumbed between the TG and the mass spectrometer. This interface allows continuous monitoring of the ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) used to elucidate the TG transitions attributable to residual moisture in freeze-dried biological products. Moisture specifications must be met in order to insure product stability throughout the approved shelf life. TG/MS results are discussed for BCG Vaccine, BCG Live (Intravesical) and U. S. Standard Antihemophilic Factor. Karl Fischer and TG/MS moisture results are compared.
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页码：929 / 936
页数：7
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