Shimadzu has launched the Co-Sense for Impurities System for the quantitative analysis of impurities in drugs.

This high-performance liquid chromatography application system achieves reliable separation of trace impurities and 20 times higher sensitivity than conventional liquid chromatography systems. It features online trapping to enhance sensitivity through automatic online concentration of the target impurities. Dedicated control software offers easy and visual system settings. This product is part of the Co-Sense series of liquid chromatography application systems jointly developed by Shimadzu and Eisai Co., Ltd.

?What Is the Co-Sense Series?

Co-Sense is an acronym for “Collaboration of Shimadzu Eisai New Systematic Efficiency.” Jointly developed by Shimadzu and Eisai Co., Ltd., previously released systems include the Co-Sense for MS and Co-Sense for NMR Automated Sample Pretreatment Systems for LC/MS and NMR, the Co-Sense for CV Cleaning Validation Support System, and the Co-Sense for BA Automated Sample Pretreatment System for Bioanalysis.

Background to the Product Development

The draft guidance, “Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches,” issued by the US Food and Drug Administration (FDA) in 2008, demands the analysis of more minute (approximately one-twentieth) levels of impurities with severe genotoxic, carcinogenic, or other side-effects. High-sensitivity quantitation of impurities is possible by LS/MS using a simple LC system. However, manufacturing processes, for example, demand a more sensitive quantitation method using an absorbance or other conventional detector that offers excellent stability and low running costs.

The product features are listed below.

(1) 20x Higher Sensitivity Permits High-Sensitivity Analysis of Trace Impurities

This system features automatic online sample concentration that concentrates trace impurities and increases the measurement sensitivity 20 times compared to conventional systems. By using an absorbance or other normal detector, high-sensitivity analysis with excellent stability and low running costs is achieved.

(2) 2-D Separation Ensures Reliable Separation of Trace Impurities

Using two LC systems with different separation characteristics ensures reliable separation and sensitive, highly accurate quantitation of trace impurities in cases where adequate separation of the main components from impurities is difficult using conventional methods.

(3) Dedicated Control Software Lets Anyone Operate the System

Significant knowledge and experience are generally required to set the analytical conditions and clean the flow lines of a 2-D separation system. However, the graphical user interface of the dedicated control software is so clear that anyone can operate this system.

? What Is a 2-D Separation System?

A normal high-performance liquid chromatograph (HPLC) detects the sample after separation in a single column. By online introduction of the eluate (mobile phase) containing the components separated in the first column into a second column, a 2-D HPLC achieves greater separation of components. This system uses a first-dimension column with a larger inner diameter than a normal analytical column to allow introduction of large sample volumes. A column with a finer inner diameter is used as the second-dimension column to increase the sensitivity.

The new Co-Sense for Impurities System is one of the application systems that exploit the superb expandability of Shimadzu’s modular high-performance liquid chromatographs. Shimadzu aims to expand its share of domestic and overseas liquid chromatograph markets by offering such application systems, which meet the needs of the end user.