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Shimadzu Corporation announces the release of LabSolutions MD, support software for analytical method development for high-performance liquid chromatography (HPLC).

Strict quality control is required for pharmaceuticals, and this type of analysis is mainly performed using HPLC. Accurate, highly reliable analysis improves the safety of pharmaceuticals. Optimal analytical methods are developed by the pharmaceutical manufacturers. There have been issues, however, with the need to try a variety of analysis conditions, which takes time, and the fact that analytical method development expertise differs from person to person, and judgments in the development process depend on an operator’s experience.

In response to these issues, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has proposed Analytical Quality by Design (hereinafter AQbD), a method of clarifying the details and basis for developing analytical methods, as well as evaluating and verifying these methods. The approach in developing methods based on AQbD is to emphasize scientific foundations and risk assessment. Examining analytical conditions comprehensively without relying on the operator’s experience or intuition heightens reliability, enabling the development of low-risk analytical methods. At the same time, however, there have been issues with the need for specialized knowledge of statistics and the additional workload of creating evaluation results.

LabSolutions MD software, which is based on AQbD, heightens the efficiency of the entire analytical method development sequence, from data collection via the experimental design method^*1 to visualization via a design space^*2, enabling the development of the optimal analytical method even by inexperienced operators. In addition, LabSolutions MD is available for the Shimadzu LabSolutions analysis data system, so it can be integrated seamlessly. The software provides integrated management of related analysis results and reports in a LabSolutions database, ensuring data reliability.

Shimadzu will continuously contribute to ensuring the reliability of analysis data and the safety of pharmaceuticals through software products and services with the LabSolutions brand.

*1 Experimental design method: A statistical method for performing condition searches efficiently
*2 Design space: A method of confirming that analysis conditions carry the lowest risk by visualizing the relationship between the analysis conditions and the analysis results

Features

1. More Efficient Condition Searches Using the Experimental Design Method

Conventionally, a significant amount of analysis was required to search for the optimal analysis conditions. This software can heighten the efficiency of condition searches by collecting data utilizing the experimental design method. The number of condition search trials can be reduced by approximately 70 %.

2. Visualizing the Optimal Analysis Conditions

The relationship between analysis conditions and analysis results is visualized using the so-called design space method. Visualizing the region of the analysis results that is unaffected even if the analytical conditions are changed simplifies the determination of whether the analysis conditions are low risk and as dependable as possible. The software can even run analysis results simulations with the specified conditions.

3. Integrated Database Management of the Analytical Method Development Process

The software can output reports combining the data collected and the results of analysis via design space. In addition, the software can provide integrated management of the entire sequence of files in a database in the LabSolutions analysis data system, so data integrity is ensured.

LabSolutions MD Software Window

For more details, visit
LabSolutions MD