title: Evaluation of a compact mass spectrometer for routine support of pharmaceutical chemistry.
abstract: 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.
authors.affiliation: Analytical Chemistry, Merck Research Laboratories, Rahway, NJ 07065, USA. Electronic address: xiaodong_bu@merck.com.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Bu
authors.affiliation: Analytical Chemistry, Merck Research Laboratories, Rahway, NJ 07065, USA.
authors.forename: Jiong
authors.initials: J
authors.lastname: Yang
authors.affiliation: Analytical Chemistry, Merck Research Laboratories, Rahway, NJ 07065, USA.
authors.forename: Xiaoyi
authors.initials: X
authors.lastname: Gong
authors.affiliation: Analytical Chemistry, Merck Research Laboratories, Rahway, NJ 07065, USA. Electronic address: christopher_welch@merck.com.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Welch
mesh_terms: D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination; D013058:Mass Spectrometry / Q000295:instrumentation* / Q000379:methods*; D008970:Molecular Weight; D004364:Pharmaceutical Preparations / Q000032:analysis*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Analytical instrumentation; Compact mass spectrometry; Fit-For-Purpose; Impurity identification; Pharmaceutical process research