Ghost Peaks from Nitrile Glove Contamination in Reversed-Phase LC Drug Analysis
January 01, 2016
An unusual source of contamination was found in the reversed-phase LC analysis of a 0.4% (w/w) drug product during the development stability studies at levels much greater than the 4 ppm limit of quantitation. System-related sources (mobile phase, injector carryover and contamination), formulation components (drug substance, excipients), and the sample-handling procedure were studied by a systematic approach. The evaluation of the sample-handling procedure identified extractables from the sample vial (different from that specified in the analytical method) and the rubber-lined vial cap, and incidental transfer of residue from commonly used nitrile gloves as the sources of unintended contamination in sample analysis.