复合材料溶出物检测 | Identifi cation and Comparison of Extractables in Drug Container Closure Systems-安捷伦科技(中国)有限公司

方案摘要

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应用领域	制药/生物制药
检测样本	复合材料
检测项目	溶出物
参考标准	-

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.

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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.

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