The detection sensitivity is a measure used to ensure the suitability of a given chromatographic procedure for the complete detection of the impurities in the
Chromatographic purity or
Related compounds tests by injecting a volume of a quantitation limit solution equal to that of the
Test solution. Unless otherwise specified in the individual monograph, the quantitation limit solution may be prepared by dissolving the drug substance Reference Standard in the same solvent as that used for the
Test solution at a 0.05% concentration level relative to the amount of drug substance in the
Test solution for drug substances, and a 0.1% level relative to the amount of drug substance in the
Test solution for drug products. The signal-to-noise ratio for the drug substance peak obtained with the quantitation limit solution should be not less than 10.
USP29 (Official June 1, 2006)