In order to demonstrate the quality of pharmaceutical products, pharmaceutical manufacturers must perform process studies into the active pharmaceutical ingredients (API) and studies into the pharmaceutical preparation process, and quality assessment for both of these as part of their chemistry, manufacturing, and control (CMC) activities. HPLC is used widely in such investigations for reaction tracing and impurity identification in API process studies, uniformity testing, and dissolution testing in pharmaceutical preparation development studies, and for analytical method validation in assay development for quality assessment studies.
The results of these studies must be tabulated according to the objectives and summarized in reports. It is often the case that these results are copied into Excel or similar software before a report is created. This article describes three examples of how the LabSolutions Multi Data Report feature is used in pharmaceutical development studies.
(1) API process studies: Outputting scouting results for chiral compounds
(2) Pharmaceutical preparation development studies: Outputting trend plots for dissolution testing
(3) Quality assessment studies: Outputting results from analytical method validation