On-line Monitoring of Synthetic Reactions Using Nexera FV

User Benefits

- On-line monitoring of synthetic reactions is enabled using Nexera FV. Simple switching to the Nexera ultra-high performance liquid chromatograph is possible. - The dedicated software enables automatic sampling according to the specified sampling interval. - The automatic pretreatment function provides automatic operations from sampling to dilution.

Introduction

In the pharmaceutical and fine chemical industries, there is an increasing demand to switch from conventional batch manufacturing, the mainstream method, to integrated continuous manufacturing from drug substance to drug product. Expected benefits of continuous manufacturing include reduced environmental load, increased efficiency (labor and human resources savings), and improved quality and safety. The International Conference on Harmonization (ICH), which discusses international guidelines for pharmaceuticals, has issued ICH Q13, a guideline for the continuous manufacturing of pharmaceuticals in 2022, and this has encouraged active consideration of continuous manufacturing in Japan and abroad. Based on above mentioned reasons, the demand for Process Analytical Technology (PAT) for quality control in each process is increasing. The Nexera FV is an HPLC system equipped with an autosampler and flow through vials for on-line analysis in flow synthesis (Fig. 1). By using flow through vials and an external syringe unit, the system can automatically perform all processes of sampling from a synthesis vessel, HPLC analysis, and report output. This article introduces an on-line monitoring using Nexera FV, using the esterification reaction of carboxylic acids as a model case.

March 20, 2024 GMT