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The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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