Monitor lyophilization with mass spectrometer gas analysis.

J P Connelly, J V Welch
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Abstract

This paper presents a brief review of the basic issues of lyophilization and the fundamentals of quadrupole mass spectrometry. The emphasis of the paper is on the application of a quadrupole mass spectrometer as a process monitor. The details of sampling and data collection are discussed. Data taken while monitoring lyophilization is presented in conjunction with cycle optimization, end point detection and contaminant detection.

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用质谱仪气体分析监测冻干过程。
本文简要介绍了冻干的基本问题和四极杆质谱法的基本原理。本文重点介绍了四极杆质谱仪在过程监测中的应用。讨论了采样和数据收集的细节。在监测冻干过程中采集的数据与循环优化、终点检测和污染物检测结合在一起。
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Evaluating out-of-specification laboratory results. Simplifying and improving process validation. Depyrogenation of pharmaceutical solutions using submicron and ultrafilters. USP perspectives on particle contamination of injectable products. Moisture measurement: a new method for monitoring freeze-drying cycles.
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