Analysis of Impurities and Degradants Using a New Open-Access LC/MS/MS Software System in a Pharmaceutical Development Environment

摘要

With the new open access system, a chemist can change the gradient condition during the log-in of the samples to be analyzed. With a typical 30 minute impurity/degradant profile gradient analysis, up to 30 samples are analyzed in any given 12 hour day. Samples can be queued for analysis overnight, increasing the number of samples to approximately 60 per day. The intuitive interface provided by the software allows novice users to approach and successfully use the system with very little training, and provides the system administrators with confidence in deploying new methods. An example of the nominal mass accuracy of this method for the analysis of a Magainin peptide is shown.