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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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

Level of Regulatory Requirements

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...
Trap concentration of ultra-trace impurities achieves ultrasensitive analysis

The Co-Sense for Impurities System achieves approximately 10 to 20 times higher sensitivity than 1-D separation only by...
2-D Separation Ensures Reliable Separation of Trace Impurities

Using a 1-D and 2-D column with different retention characteristics, or using different mobile phase compositions, permits reliable separation and...
Dedicated Control Software Lets Anyone Operate the System

Significant knowledge and experience are generally required to set the analytical conditions and clean the flow lines of a 2-D separation system. However...

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