0

    Co-Sense for Impurities

    Liquid Chromatograph with online Sample Preparation

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    The FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" prescribes permitted limits for genotoxic impurities in drug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

    Features

    Weitere Informationen

    Neuigkeiten und Veranstaltungen

    Weitere Informationen