Shimadzu has released the Nexera FV ultra high performance liquid chromatograph (UHPLC, abbreviated below as LC) for online analysis. In online analysis, samples are collected automatically from the manufacturing process and injected consecutively into the analysis instrument. This product is connected directly to a synthesis reactor or dissolution testing machine (hereinafter “peripheral equipment”). After the raw materials or pharmaceutical samples are placed in the peripheral equipment, tasks up to data acquisition by the LC are performed automatically.

In synthesis evaluations, which are performed during research and development in order to improve the process of manufacturing chemical products, dissolution tests, conducted to check the formulation dissolution rate, and quality control, sample analysis is performed after sampling from the peripheral equipment at set intervals. In this process, the samples must be transferred and replaced manually, which may lead to human error while simultaneously placing a heavy burden on the analyst in terms of time and task difficulty. In recent years, the flow method, which involves continuous production, has become widely adopted as a synthesis method for chemical products, as adjustments to mass production are easy with this method and the equipment is compact. However, even with the flow method, chemical products must be repeatedly analyzed and checked during the manufacturing process, so there is a heightened need for automation.

With the Nexera FV, samples are automatically injected into the LC from the peripheral equipment via an autosampler (automatic sample injector) equipped with a newly developed flow vial kit. It can operate continuously without an analyst, enabling continuous sampling and analysis even overnight. Dedicated software (LabSolutions FV) simplifies the setting of sampling timing and analysis mode, as well as the data analysis of the results. Three instrument configurations are available. One is for flow synthesis systems to check the status of chemical products produced continuously; one is for batch synthesis systems to check quantitative changes in the product materials and raw materials contained in the chemical products manufactured; and one is for dissolution tests and quality control processes. The Nexera FV is based on the Nexera series, Shimadzu’s mainstay LC which provides outstanding performance and excellent usability. Customers who already have a Nexera series instrument can upgrade to the Nexera FV UHPLC for online analysis by adding the flow vial kit.

Shimadzu will continue to promote analytical transformation (AX, the automation of analytical and measuring instruments), which is producing a business revolution for customers by improving productivity, thereby contributing to research and development and quality control in the pharmaceutical industry.

Features

1. Reducing Labor Costs and Risks by Automating Synthesis Evaluations

The autosampler, which is equipped with a newly developed flow vial kit, automatically injects samples from synthesis reactors and flow synthesis systems into the LC,^*1 starting the analysis. Everything up to data acquisition, data analysis, and the creation of reports is automated, thereby preventing human error and saving on labor.

2. Provides Labor Savings and Heightened Efficiency in Dissolution Testing

In dissolution testing, automating sampling reduces the time spent on transferring and replacing samples by approximately 35 %,^*2 enabling a more efficient workflow. For formulations with short dissolution times that require quick sampling over multiple cycles, up to 384 samples can be collected, so the instrument can be used in a variety of ways.

3. Dedicated Software Simplifies Operations and Improves Reliability

When analysis is performed with the instrument connected to peripheral equipment, schedules must be designed according to the sampling timing and analysis conditions, which is a troublesome task. LabSolutions FV, the dedicated software for the Nexera FV, automatically creates analysis schedules after the related information is configured, and automatically outputs analytical results reports after analysis using the LC is finished. With the optional multi-data report function, the progress of synthesis reactions and changes in the dissolution rate over time can be checked visually. This reduces the time and labor spent prior to starting analysis and, at the same time, reduces the risk of analysis failures due to setting mistakes, thereby contributing to labor savings and improved data reliability.

• *1 If filtration or other pretreatment is not required.
  *2 Depending on the analysis conditions

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Nexera FV