药包材中萃取物和浸出物检测方案(液相色谱仪)

.Agilent Technologies Extractables and Leachables Detected inOphthalmic Drug Products 摘要： Compounds leaching from container closure systems can cause contamination to drug substances orproducts. As part of a risk evaluation， it is necessary to identify these compounds and ensure that thedrugs are suitable for their intended use. Typically， such compounds are present at low concentrationsand are masked by the drug matrix. Therefore， highly sensitive and selective methods are required todetect and identify these compounds. Quadrupole time-of-flight (Q-TOF) mass spectrometers aresuitable for this purpose due to their high resolution and accurate mass measurement capabilities.An Agilent 1290 Infinity LC System and an Agilent 6540 Q-TOF system combined with statisticalanalysis software were used to detect and identify extractable and leachable (E&L) impurities fromophthalmic drug products. Statistical data analysis was performed using Agilent Mass ProfilerSoftware (MP) to determine the compounds present in the samples compared to controls. Thedatabase search tool within MP software helped to identify E&Ls using a customized accurate massdatabase. For the identification of unknown E&Ls， MS/MS data together with the structure predictionsoftware， Molecular Structural Correlator， was used. In this study， 50 compounds were detected ineach of the E&L samples. Compounds leaching from container closure systems can cause contamination to drug substances or products. As part of a risk evaluation, it is necessary to identify these compounds and ensure that the drugs are suitable for their intended use. Typically, such compounds are present at low concentrations and are masked by the drug matrix. Therefore, highly sensitive and selective methods are required to detect and identify these compounds. Quadrupole time-of-flight (Q-TOF) mass spectrometers are suitable for this purpose due to their high resolution and accurate mass measurement capabilities. An Agilent 1290 Infinity LC System and an Agilent 6540 Q-TOF system combined with statistical analysis software were used to detect and identify extractable and leachable (E&L) impurities from ophthalmic drug products. Statistical data analysis was performed using Agilent Mass Profiler Software (MP) to determine the compounds present in the samples compared to controls. The database search tool within MP software helped to identify E&Ls using a customized accurate mass database. For the identification of unknown E&Ls, MS/MS data together with the structure prediction software, Molecular Structural Correlator, was used. In this study, 50 compounds were detected in each of the E&L samples.