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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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
-
-
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 | Creation Date |
|---|---|
|
2012-09-18 |
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 -"