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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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.
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
Shimadzu has released the Method Scouting System.
Method Scouting System is a method development system based on Shimadzu’s UHPLC technology.
Shimadzu has released the Nexera MX.
Nexera MX processes twice the number of samples as conventional LCMS systems in the same amount of time.
“Advanced i-Series” High Performance Liquid Chromatograph
Retaining the excellent basic functions of the flagship “i-Series”, the Advanced i-Series boasts increased pressure resistance and additional functions to support remote work including working from home.
Shimadzu has released the ELSD-LT III Evaporative Light Scattering Detector for HPLC.
The evaporative light scattering detector (ELSD) is a general-purpose universal detector that can even detect components with no UV absorption, such as carbohydrates, lipids, surfactants, and synthetic polymers.
Shimadzu has released the Microsampling Device, MSW2™ Type Udck™
For Research Use Only. Not for use in diagnostic procedures.
Application Note: "Analysis of Pharmaceuticals' Impurity - Regulations and Analysis for Carcinogenic Substances -"