Evaluation of a compact mass spectrometer for routine support of pharmaceutical chemistry

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• 作者：Xiaodong Bu ; ^{xiaodong_bu@merck.com" class="auth_mail} ; Jiong Yang ; Xiaoyi Gong ; Christopher J. Welch ; ^{christopher_welch@merck.com" class="auth_mail}
• 关键词：Compact mass spectrometry ; Fit-For-Purpose ; Analytical instrumentation ; Pharmaceutical process research ; Impurity identification
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：June, 2014
• 年：2014
• 卷：94
• 期：Complete
• 页码：139-144
• 全文大小：1722 K

文摘

The suitability of a recently introduced inexpensive, compact mass spectrometer detector is evaluated for supporting pharmaceutical chemistry investigations. While high performance/high cost MS detectors dominate the marketplace, there is growing recognition of the need for a small, inexpensive MS detector with reduced capabilities for supporting synthetic chemistry investigations, where reduced sensitivity and unit mass resolution are often suitable for solving routine problems. In this study, the fundamental performance characteristics of the recently introduced Advion compact mass spectrometer were evaluated, investigating the use of the instrument for routine product and impurity identification, reaction monitoring, evaluation of potential genotoxic impurities and study of high molecular weight biomolecules. In general, the results of the evaluation show this compact and inexpensive mass spectrometer to be well suited for providing reliable support for pharmaceutical chemistry investigations, with sub-nanogram limit of detection and impurity identification below 0.1% being possible in some instance.