Example: For a 30 mg daily...
Co-Sense for Impurities
Liquid Chromatograph with online Sample Preparation

The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug substances. These impurities demand more sensitive trace-level analysis than normal impurities. Generally, mass spectrometry methods, such as GC/MS or LC/MS, are used for the high-sensitivity analysis of impurities. However, there is increasing demand for the establishment of a high-sensitivity quantitation method using an absorbance or other conventional detector that is easy to operate and can easily apply existing LC analysis conditions.
Features
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Impurity intake restricted to 1.5 µg/day max. when taking a drug over a long period (12 months or more)
Example: For a 30 mg daily... -
The Co-Sense for Impurities System achieves approximately 10 to 20 times higher sensitivity than 1-D separation only by...
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Using a 1-D and 2-D column with different retention characteristics, or using different mobile phase compositions, permits reliable separation and...
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Significant knowledge and experience are generally required to set the analytical conditions and clean the flow lines of a 2-D separation system. However...
News / Events
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Determination of heterocyclic oxygen compounds in Citrus essential oils by Supercritical fluid chromatography-tandem mass spectrometry
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New Nexera UC Prep Semi-Preparative Supercritical Fluid Chromatography System
Semi-Preparative Supercritical Fluid Chromatography System
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New Nexera UC Supercritical Fluid Extraction / Supercritical Fluid Chromatograph
Nexera UC improves your analytical workflow by utilizing a completely new separation technology, Unified Chromatography, which unites sample separation, analysis with various separation modes, and high-sensitivity detection.
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New Nexera Prep Preparative Purification Liquid Chromatograph
The Nexera Prep Purification System provides optimal solutions for your laboratory needs.
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Shimadzu has released the Shim-pack™ SUR-Na Columns for Ligand Exchange Chromatography.
Shim-pack™ SUR-Na, a ligand exchange chromatography column, offers excellent performance by combining size exclusion mode and sodium-based ligand exchange mode to provide superior separation of sugar components. Pure water can be used for the mobile phase, resulting in less effort to prepare for the analysis.
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Efficient Method Development by automated pH Screening with LabSolutions MD
This article describes an example of using LabSolutions MD, a dedicated software for supporting method development, to automate pH screening by varying the mobile phase pH from 2.5 to 8.5 to evaluate the optimal pH level for separating 12 small-molecule drugs.