选择性高亲和力配体的杂质分析

前言：

Impurity analysis using LC-MS and differential analysis software to determine impurities between two synthetic pathways for a drug with potential in treating Non-Hodgkin’s Lymphoma.

Methods: A bench-scale synthesis of the drug is compared to the first batch of a pilot production synthesis. LC-MS (positive mode) using an Open Accela Autosampler coupled to a Thermo Scientific LTQ Orbitrap XL mass spectrometer followed by SIEVE™ 2.0 software analysis. Thermo Scientific Mass Frontier 7.0 software used for determination of fragments and fragmentation pathways.

仪器： Thermo Scientific LTQ Orbitrap XL

结论：

High resolution spectra and ion trap MSn data was used to elucidate an abundant impurity present in both products as a chromium chelate to the DOTA structure. Differential analysis software identified a number of differences between the two samples. The extracted ion chromatograms were reconstructed from the HRAM data and elucidation of impurities was performed by ion trap MSn and Mass Frontier™ software.