Liquid Chromatograph with online Sample Preparation, For Co-Sense for Impurities

The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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.

• Level of Regulatory Requirements
• Trap concentration of ultra-trace impurities achieves ultrasensitive analysis
• 2-D Separation Ensures Reliable Separation of Trace Impurities
• Dedicated Control Software Lets Anyone Operate the System