This article describes the sensitive impurity detection of drug intermediates produced by Agilent Technologies, Inc. High purity standards are required for drug intermediates in the production of flurazepam, enalapril, and flunarizine. The Agilent LC/MSD Ion Trap was used to obtain LC/MS and MS/MS data for each intermediate, providing sufficient information to propose structures for the corresponding impurities.
This document describes the application of the Agilent LC/MSD Ion Trap system for the sensitive detection and identification of impurities in fine chemicals and drug intermediates. The text highlights the importance of purity standards in drug production and the risks associated with impurities.
| System Configuration | Agilent LC/MSD Ion Trap SL with 1100 binary pump and well plate autosampler |
|---|---|
| Sample Concentration | 5 to 10 mg/mL |
| Injection Volume | 1 uL |
| SmartFrag Range | 20% to 200% of fragmentation amplitude |
The Auto MS/MS capability with the application of the powerful SmartFrag allows for obtaining precursor ion and representative fragmentation in one LC/MS and MS/MS run.
No, MS/MS alone is insufficient for positive identification of an unknown; comparison with an authenticated reference is required.
Matching chromatographic retention time with an authenticated standard provides additional confirmation.