For the pharmaceutical characterization and development phase, major tasks include new compound identification and sample-to-sample comparisons to identify key differences. These workflows are relevant for example to Metabolite-Identification, Impurity Analysis and the Extractables and Leachables analysis. In the first half of this presentation, we will present how Compound Discoverer software streamlines these workflows for both LC- and GC- HRAM MS analysis. A thorough review of chromatography data is essential when the results will be used in making cGMP decisions. The data review process requires more than just determining if the result passes or fails, it also must consider how the data was generated in order to demonstrate its compliance with regulations. On the second half of this presentation, we will discuss how Chromeleon CDS simplifies the process by making the most useful information easily accessible during data review.
Solutions to simplify major pharmaceutical characterization and development analysis with Compound Discoverer
Introduction to Chromeleon CDS compliance features, including those specific to GC-MS and LC-MS
Understanding of a streamlined data/audit trail review process using Chromeleon software