Since the spring of 2016, the U.S. Food and Drug Administration (FDA), the British Medicines and Healthcare products Regulatory Agency (MHRA), and other regulatory agencies have strengthened the monitoring of quality assurance at pharmaceutical companies. Companies must now show that nothing improper has been done when using analytical instruments.
In addition, in graphs showing data acquired from liquid chromatographs and other analytical instruments, if the separation of target components and impurities is insufficient, manual peak integration*1 is needed in order to accurately detect and quantify the peaks (mountain-shaped waveforms in the graph, indicating component detection) for each component. So-called shoulder peaks, waveforms in which component peaks overlap, are particularly difficult to determine, and are a cause of concern for operators. The new peak integration algorithm built into this product can more accurately quantify shoulder peak components. The peak separation function*2, which uses UV spectral information from compounds, has also been improved, and can be used to obtain accurate quantitative values.
| *1: | In this type of processing, peaks are detected from the signal intensity time series data, and the peak areas and heights are obtained. |
| *2: | This peak separation function was developed in collaboration with Eisai Co., Ltd. |