Keywords关键词: OPTIC, IMS, AIMS, Clopidogrel
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
Analyzer分析仪: | OPTIC-AIMS, GL Sciences. MaSaTech. |
Transfer Line导管: | Fused Deactivated Silica, 0.25mm x 0.1 m |
Temperature transfer line导管温度: | 200°C |
Injection mode进样模式: | OPTIC Expert mode |
Sample volume样品体积: | 1 µL sample |
Inlet temperature program温度程序: | 50°C 、60.0 °C/s、400°C Column Flow: 20.0 mL/min conditioned Air |
Venting排气: | 75 mL/min conditioned Air, 6 sec |
Drift tube temperature飘移管温度: | 180°C |
Drift Flow漂移气体流量: | 900 mL/min conditioned Air |
Analysis Time分析时间: | 150 s (including cool down time) |
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
关注
离子迁移谱技术用于工业大麻CBD分析研究
离子迁移谱技术用于橄榄油分类鉴定
Enea创造了新的Csi和Ncis犯罪现场勘察技术
SCS产品免费校准维护服务活动通知
相关产品
关注
拨打电话
留言咨询
