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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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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Don’t miss out! Join our latest webinar collaborated with SelectScience on June 28, 2022.
“Dual deconvolution of LC-PDA-MS data: A fast-track approach for chemical composition and impurity analysis”
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Shimadzu has released the LCMS-2050 High-Performance Liquid Chromatograph Mass Spectrometer.
The LCMS-2050 single quadrupole mass spectrometer combines the user-friendliness of an LC detector with the excellent performance of MS to provide a complete package of easy to use high-level performance and compactness.
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LabSolutions CS has been upgraded to Ver. 6.115.
LabSolutions CS features an innovative operating environment and provides complete data management to ensure secure information in networked laboratories.
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Shimadzu has released the CoreFocus Library.
CoreFocus Library is a digital library where you can find and learn different methods for analyzing your target compounds.
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Shimadzu has released the Nexera XS inert.
The Nexera XS inert system offers the ideal solution for the separation of biomolecules by combining the elevated pressure tolerance of a UHPLC system with complete inertness of the sample flow path, ensured by the absence of wetted metal surfaces and offering ultra-high resistance to corrosion.
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Shimadzu has released Method Development System
LabSolutions MD uses an “Analytical Quality by Design” (AQbD) approach for achieving efficient method development by designing analysis methods based on science and risk. All workflow steps can be completed using LabSolutions MD, including analyzing samples using the experimental design, building a design space by using the analytical results, and evaluating robustness after deciding the optimal analytical conditions.