Automated Targeted Screening of Leachables in Pharmaceutical QC Labs Using the Agilent LC/MSD XT and Agilent OpenLAB CDS

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This Application Note describes a routine analysis workflow for pharmaceutical QA/QC labs. Organic nonvolatile leachables from ophthalmic drug products were identified and quantified using an Agilent Liquid Chromatograph/Mass Selective Detector XT (LC/MSD XT), based on single quadrupole technology, with the Agilent 1260 Infinity II LC system and Agilent OpenLAB CDS Software. The newly designed OpenLAB CDS has several advantages for targeted screening, such as reference spectral matching, quantification with quantifier and qualifier ions, and suspect identification using library searches. The software enables a complete 21 CFR Part 11 compliance solution that includes data security, integrity, and

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تاریخ انتشار 2017