其他溶出物检测 | Differential Analysis in Screening Assays for Extractable and Leachable Compounds-安捷伦科技(中国)有限公司

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应用领域	制药
检测样本	其他
检测项目	溶出物
参考标准	-

The analysis of extractable and leachable (E&L) compounds presents challenges for data interpretation and compound identification. The interpretation of data for controls and samples is traditionally performed manually, and can be very time-consuming.

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The analysis of extractable and leachable (E&L) compounds presents challenges for data interpretation and compound identification. The interpretation of data for controls and samples is traditionally performed manually, and can be very time-consuming. Software-based data interpretation greatly alleviates this challenge. Mass Profiler Professional (MPP), a chemometric software application, performs differential analysis, and provides a means to readily visualize the

distribution of compounds across samples.

The identification of compounds encountered during E&L analysis using GC/MS with electron ionization (EI) requires a degree of specialized knowledge. The use of EI often results in a mass spectrum that does not contain a distinct molecular ion, and identification is dependent on matching characteristic fragmentation patterns. In E&L studies, fragmentation matching scores can be relatively poor, where compounds are present in minor concentrations or interfered by strong chemical background noise. Therefore, not all compounds may be identified unequivocally based on their fragmentation pattern alone. In this study, an Ophthalmic Drug Product (ODP) and its container closure system were analyzed using an accurate mass high resolution Agilent 7200 GC/Q-TOF system in both EI and chemical ionization (CI) modes.

上一篇使用 Agilent 5800 ICP-OES 测定固态电解质锂镧锆钽氧 (LLZTO) 中的主量元素

下一篇 EXTRACTABLES AND LEACHABLES: A COMPLEX ANALYSIS

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安捷伦科技(中国)有限公司

钻石会员丨第23年

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