Example: For a 30 mg daily...
Co-Sense for Impurities
Liquid Chromatograph with online Sample Preparation
![Co-Sense for Impurities](/an/sites/shimadzu.com.an/files/d7/ckeditor/an/qn5042000000hmmk-img/qn5042000000hmoy.jpg)
The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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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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.
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Oxygen heterocyclic compounds profile evaluation in cold-pressed Citrus essential oils using supercritical fluid chromatography coupled to photodiode array detector
A large number of analytical techniques to characterize the non-volatile composition of Citrus essential oils (EOs) were introduced in the literature. However, the reports of Citrus EOs analysis by supercritical fluid chromatography (SFC) with UV or mass spectrometry detectors for the analysis of non-volatile polar compounds are still few.
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Shimadzu has released the Shim-pack Mix-HILIC, Chromatography Column for Hydrophilic Interactions
Comprehensive Analysis of Hydrophilic Metabolites in Metabolomics
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A new video has been released -Finding Out What Makes Things Sour-
Ever wondered what makes some foods sour? In this video we explore that question while also introducing one of Japan's traditional sour foods!
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New Nexera FV
Nexera FV and LabSolutions™ FV together form a new UHPLC system capable of monitoring flow synthesis and batch synthesis reactions, and automating formulation dissolution testing.