Shimadzu’s Updated LabSolutions Analytical Data System
Adds Supplementary Data Integrity Functions for the Pharmaceutical Industry
Shimadzu Corporation has released the latest version of its LabSolutions analytical data system. This product incorporates supplementary functions to comply with data integrity regulations, and support development and quality inspection procedures in pharmaceutical companies.
Background to the Development
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.
1. New Peak Integration Algorithm Enables High Accuracy Peak Detection
The new algorithm automatically detects peaks without the need for special settings. With manual peak integration, differences in results tend to occur due to different operators, so it is hard to ensure data integrity. The mechanical automatic detection function helps to supplement data integrity.
2. Accommodates Complicated Waveforms from Multi-Component Simultaneous Analysis
The proprietary peak integration function enables accurate detection of peaks, lessening the burden involved in analyzing data and checking test results.
3. Peak Separation Using Spectral Pattern Differences
A new function uses differences in the UV absorption spectral patterns of eluted components to reliably separate multiple components eluted at basically the same time. Hard-to-separate peaks can be separated into single peaks, simplifying detection, and at the same time, enabling analysis and quantitative calculations with respect to the resulting data. In addition to pharmaceuticals, this revolutionary solutions can be used for the analysis of clinical specimens, chemical products, natural products, functional foods, and residual pesticides.
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LabSolutions Peak Integration Algorithm