Coupling ultra-performance convergence chromatography to mass spectrometry provides an important tool for pharmaceutical analysis.

	The authors describe the use of convergence chromatography combined with mass spectrometry for impurity profiling. This was achieved by using metoclopramide and its related substances and metoclopramide drug products as examples.

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The authors describe the use of convergence chromatography combined with mass spectrometry for impurity profiling.

Impurity Profiling Using Convergence Chromatography and Mass Spectrometry

The authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis. The authors determined the relative abundance of process-related proteins and a specific residual impurity by use of an internally standardized MRM-MS technique for a recombinant fusion protein.

The authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.

Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical Analysis

Simultaneous quantitative and qualitative collection of information from a drug-metabolism and pharmacokinetics analysis can increase productivity in drug discovery and development. These two data sets are traditionally collected from two parallel sample lines, run at differing concentrations, and often on separate liquid chromatography–tandem mass spectrometry (LC–MS/MS) instruments because of LC–MS technology. Most current LC–MS/MS systems offering the high mass accuracy required for metabolite identification lack the sensitivity and linear range to perform quantitative bioanalysis at therapeutic dosing levels.

	This article presents the successful analysis of metabolic products from microsomal incubations of a common pharmaceutical compound. Using quadrupole time-of-flight mass spectrometry, the author obtained clearance data, metabolic identification, structural elucidation, and metabolic profiles from a single sample set.

This article presents the successful analysis of metabolic products from microsomal incubations of a common pharmaceutical compound.

Simultaneous Quantitative and Qualitative Measurements in Drug-Metabolism Investigations

The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics. IgG monoclonal antibody spiked with low abundant proteins was used as the model to test the assay sensitivity and dynamic range. The simultaneous qualitative and quantitative analysis of low abundance proteins was achieved with single injection on a hybrid quadrupole-Orbitrap mass spectrometer.

	This LC–MS based approach can be applied for host-cell proteins generated during drug process development by recombinant DNA technology.

The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.

Identification and Quantification of Trace-Level Protein Impurities

The authors present an analysis of ibuprofen based on United States Pharmacopeia General Chapter <621> “Chromatography” using high-performance liquid chromatography that employed a method-scouting system with a conventional column (i.e., standard octadecyl silica column) and a core-shell column.

The authors present an analysis of ibuprofen based on United States Pharmacopeia General Chapter  “Chromatography” using high-performance liquid chromatography.

Ultra-High-Speed Analysis of Ibuprofen Using HPLC

Highly specified drug-delivery systems require specific quality evaluation during the development stage. The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample three-dimensionally, underneath, and at the surface in a nondestructive manner.

The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.

Pharmaceutical Technology-07-15-2013

Impurity Profiling Using Convergence Chromatography and Mass Spectrometry

Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical Analysis

Simultaneous Quantitative and Qualitative Measurements in Drug-Metabolism Investigations

Identification and Quantification of Trace-Level Protein Impurities

Ultra-High-Speed Analysis of Ibuprofen Using HPLC

Characterization with Atomic Force Microscopy, Topographic, and 3D Raman