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...
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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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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The Co-Sense for Impurities System achieves approximately 10 to 20 times higher sensitivity than 1-D separation only by... -
Using a 1-D and 2-D column with different retention characteristics, or using different mobile phase compositions, permits reliable separation and... -
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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New Method Development System
LabSolutions™ MD improves method development efficiency by taking an Analytical Quality by Design (AQbD) approach. This software efficiently develops highly reliable analysis methods by configuring mobile phases, columns, and other parameters using an analysis function that automatically generates analysis schedules with the experimental design method and a data analysis function that plots a design space and predicted chromatogram.
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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-vial™ H glass, S glass.
Shimadzu provides high-quality vials that thoroughly eliminate these risks by visually inspecting each vial, allowing them to be used with confidence.
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Shimadzu has released the MUP-3100, Fully Automated Sample Preparation Module for Glycan Analysis
Shimadzu developed the MUP-3100 Fully Automated Sample Preparation Module for Glycan Analysis in conjunction with Sumitomo Bakelite Co., Ltd., for use with their antibody N-glycan analysis kit. The MUP-3100 eliminates manual sample preparation, increases overall analysis throughput, and improves reproducibility.
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Ion Chromatography Solutions for Environmental Analysis
Shimadzu has focused on the development of instruments for environmental analysis for decades, helping scientists to detect, identify and quantify trace-level pollutants and meet environmental testing demands, for both regulatory purposes and to advance Research & Development.
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Shimadzu has released the Peakintelligence™ for LC
Liquid chromatography is now an indispensable analytical technique used in pharmaceutical, food, and a wide variety of other industries. In these industries, there is a need for efficient data analysis methods that are not user-dependent. Peakintelligence for LC software includes AI algorithm* that was developed by learning expert peak integration skills.