Method Scouting Application
Improving Efficiency in the Preparation of Test Reports for Chemistry, Manufacturing, and Control (CMC) Using Multi Data Report
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.
Ultra Fast Method Scouting (2) - Maximizing the Efficiency of Method Development
Due to the large amounts of time required for determining analytical conditions (method scouting), users are looking for ways to minimize the time required for method scouting. This report describes an example of using a Nexera Method Scouting system in combination with dedicated method scouting software to determine analytical conditions for simultaneous analysis of nine types of sulfa drugs. The dedicated method scouting software, Method Scouting Solution, is able to use the multi-data report functionality in LabSolutions DB/CS software to rapidly and optimal analytical conditions from huge amounts of analytical results. Therefore, this report also describes the multi-data report function.
Rapid Method Scouting of Chiral Compounds
Enantiomer resolution by chiral column chromatography is a variation of column chromatography that is actively being researched in the pharmaceutical field of drug discovery. One drawback of this method, however, is the extensive time and effort required to determine the optimum mobile phase conditions and the most suitable column for separation of the analyte among a wide variety of available chiral columns. This has spurred the demand for faster scouting of chiral separation conditions. Here, using the Nexera Method Scouting system with the iChiral-6 polysaccharide-based columns (Daicel Corporation), we report an example in which high-resolution column conditions are constructed for analysis of chiral compounds.