药物氯吡格雷中清洁验证检测方案(离子迁移谱仪)

Keywords关键词: OPTIC, IMS, AIMS, Clopidogrel Introduction介绍Cleaning validation is a vital step in the drug production process. It is to ensure that no cross-contamination occurs while switching between different products in a piece of equipment. Standard cleaning validation procedures are based on checking the cleanliness using liquid chromatography (LC). In average, it takes approx. 30 minutes and a significant amount of organic solvent before the production process is resumed into a next run assuming that the validation test has passed.清洁验证是药物生产过程中至关重要的一步。它是为了确保在同一设备中不同产品之间切换时不会发生交叉污染。标准的清洁验证程序是基于使用液相色谱(LC)检查清洁度。平均而言，假设验证测试已经通过，在生产过程恢复到下一次运行之前，它需要大约需要30分钟和大量的有机溶剂。 In this study it is shown that the cleaning cycle can be significantly reduced when using a fast IMS measurement technique. The cleaning examination is performed using Clopidogrel as a sample drug.在这项研究中，当使用IMS快速测量技术时，清洗周期可以显著减少。清洁检查使用氯吡格雷作为样本药物进行 Analytical conditions实验条件:Analyzer分析仪:OPTIC-AIMS, GL Sciences. MaSaTech.Transfer   Line导管:Fused Deactivated Silica, 0.25mm x 0.1 mTemperature   transfer line导管温度:200°CInjection   mode进样模式:OPTIC Expert modeSample   volume样品体积:1 µL sampleInlet   temperature program温度程序:     50°C 、60.0 °C/s、400°C Column Flow:  20.0   mL/min conditioned AirVenting排气:75 mL/min conditioned Air, 6 secDrift tube   temperature飘移管温度: 180°CDrift Flow漂移气体流量:   900 mL/min conditioned AirAnalysis   Time分析时间: 150 s (including cool down time) Sample Preparation样品制备:The samples were taken from a reaction chamber that was used to produce Clopidogrel. A swab sample was prepared by wiping the chamber horizontally on one side of the swab. Each swab sample was then placed into a 20 mL vial containing 10 mL of Methanol. The vial was shaken for 2 minutes afterwards. 1 µL of the extract was injected into the OPTIC-AIMS.这些样品是从用于生产氯吡格雷的反应室中提取。通过在拭子的一侧水平擦拭反应室，制备拭子样本。然后将每个拭子样本放入一个包含10 mL甲醇的20 mL小瓶中。然后摇小瓶2分钟。取1µL的提取液注入OPTIC-AIMS系统