药包材中萃取物和浸出物检测方案(气质联用仪)

· Agilent Technologies Identifi cation and Comparison iofExtractablesinDrug (Container ClosureSystems 摘要： Regulatory authorities and working groups provide guidelines on the evaluation of drug containers toensure the safety and efficacy of drug products. The guidelines for container qualification suggest arisk-based approach when applying an extraction study. This approach identifies and classifies thetoxicological relevance of nonvolatiles， semivolatiles， and elemental contaminants found in extractsfrom components or from the entire drug container closure system. In this work， four drug containersoriginating from different manufacturers have been investigated， generating profiles for semivolatileextractable compounds. Data were acquired on an Agilent 7200 GC/Q-TOF in both electron ionization(El) and chemical ionization (CI) modes to ensure a comprehensive identification of the extractedcompounds. El data have been acquired to identify compounds using the NIST library. Compounddistribution across the different samples was visualized based on a chemometric approach usingAgilent MassHunter Mass Profiler Professional software. Compounds that could be only tentativelyidentified after El were confirmed using parent ion mass data generated in Cl mode. Approximately170 compounds were identified in each container. The results indicate that the combination of El andCI data increased the number of identified extractable compounds， enabling a thorough evaluationof container systems. parison of Agilam Tachnsloyis In this work, four drug containers originating from different manufacturers have been investigated, generating profiles for semivolatile extractable compounds. Data were acquired on an Agilent 7200 GC/Q-TOF in both electron ionization (EI) and chemical ionization (CI) modes to ensure a comprehensive identification of the extracted compounds. El data have been acquired to identify compounds using the NIST library. Compound distribution across the different samples was visualized based on a chemometric approach using Agilent MassHunter Mass Profiler Professional software. Compounds that could be only tentatively identified after EI were confirmed using parent ion mass data generated in CI mode. Approximately 170 compounds were identified in each container. The results indicate that the combination of EI and CI data increased the number of identified extractable compounds, enabling a thorough evaluation of container systems.