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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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...
Applications
| Applications | Date Creation Date |
|---|---|
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2012-09-18 |
Technical Documents
| Technical Dosuments | Date Creation Date |
|---|---|
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2012-07-12 |
News / Events
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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.
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Registration is now open for Weight Reduction Using Composite Materials, Basic Course.
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Shimadzu has released the Nexflow technology for the Nexera system
Answering the Demand for UHPLC Analysis with a Higher Degree of Separation and Higher Sensitivity
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Shimadzu has released the Multi Liquid Handler System for the Nexera Prep Series Preparative Purification LC System
The Nexera Prep Purification System provides optimal solutions for your laboratory needs.
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Shimadzu has released the i-Series Method Transfer System
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Shimadzu has released the Nexera FV