Agilent ChemStore C/S, the database module of Agilent ChemStation Plus, offers a solution to evaluate, organize, manage and report chromatographic results imported automatically from LC, LC/MSD, CE, GC and A/D systems. In this application note we describe how Agilent ChemStation Plus helps turn chemical analysis data and peak and instrument performance data into clear and comprehensible results for a typical task of a pharmaceutical company—quality control of instruments and products.
Quality Control (QC) is a critical task in the pharmaceutical industry, requiring the evaluation of large numbers of samples and the monitoring of instrument performance to ensure product safety and regulatory compliance. This document demonstrates how Agilent ChemStation Plus, combined with the Agilent 1100 Series HPLC system, automates the transfer, management, and reporting of QC data to increase lab productivity.
The note details a model scenario involving the analysis of a cystitis tablet containing sulfamethoxazole and trimethoprim. It explains how the software generates various charts to monitor analysis results, control samples, and peak performance parameters such as symmetry, tailing factor, resolution, and selectivity, allowing analysts to identify trends and potential issues like column aging.
| Software Version | 4.06.04 |
|---|---|
| Database Version | B.01.01 |
| Column Dimensions | 4.6 x 75 mm |
| Flow Rate | 1 ml/min |
| Column Temperature | 40°C |
| Injection Volume | 5 µl |
| Detection Wavelength | 204 nm |
Monitoring these parameters helps recognize trends, such as column aging, and allows the column to be replaced before a complete breakdown occurs, preventing instrument downtime.
Control sample charts display the control sample amount against the measurement date, with a center line representing the mean value and warning/critical limits based on standard deviations.
A peak symmetry value around one indicates that the peak is symmetrical. Values higher than one suggest a tailing peak, while values lower than one suggest a fronting peak.