Shimadzu releases new UHPLC for online analysis — Supporting drug development through automation and labor saving

Shimadzu Corporation released Nexera FV, an ultrahigh performance liquid chromatograph (UHPLC) for online analysis on March 5. The price (excluding tax) is 12,580,000 yen. The price of the newly developed "Flow Vial Kit" starts at 390,000 yen. The target sales volume is a total of 20 units in Japan and abroad during the first year after release.

In online analysis, samples are automatically collected from the manufacturing process and continuously introduced into the analyzer. The new product is a system that is used by connecting directly to peripheral equipment such as synthesis reactors and dissolution testers. Once the raw materials for synthesis or pharmaceutical samples are set on the peripheral equipment, the system automates the process up to the acquisition of analysis data by UHPLC, supporting the automation of the workflow in drug development and manufacturing processes.

In synthesis evaluation performed in research and development to improve the manufacturing process of chemical products and dissolution tests performed to check the dissolution rate of pharmaceutical products in research, development and quality control, samples are removed from peripheral equipment at regular intervals and their compositions are analyzed. During this process, the samples have to be transferred manually. Resulting problems include issues such as human error and being time-consuming and complicated which places a heavy burden on the analyst.

In recent years, the use of the flow method for continuous production has been widely adopted as a chemical synthesis method that allows easy adjustment of production volume and does not require large facilities. However, the need for automation is increasing because this method requires repeated analysis and confirmation of chemicals during the manufacturing process. The new product is an autosampler (automatic sample injector) equipped with a newly developed flow vial kit that enables automatic injection of samples from various peripheral devices. The system can operate continuously and unmanned, and it allows continuous sampling and analysis, including late-night hours. The dedicated software "LabSolutions FV" makes it easy to set sample collection timing and to analyze results.

Three types of equipment configurations are available for different applications. One is for flow synthesis systems to check the status of continuously manufactured chemicals, another is for batch synthesis systems to check quantitative changes in raw materials contained in manufactured chemicals and products, and the final one is for dissolution tests used in research, development and quality control processes.

The new product is based on the "Nexera series," the company's flagship UHPLC, which offers outstanding basic performance and excellent usability. Customers who already own a Nexera series instrument can upgrade to the new product by adding the newly developed flow vial kit.