Simultaneous Analysis of API and Related Impurities Using SPD-M40 X4 Photodiode Array Detector

User Benefits

- Using SPD-M40 X4, which provides linearity up to 3 AU, enables reliable quantification over a wide concentration range from low to high levels. - In impurity analysis, the API and its related impurities can be simultaneously analyzed and quantified in a single injection.

Introduction

In pharmaceutical impurity analysis, it is desirable to quantify both the API and its related impurities. When the analysis is performed using a highly concentrated sample solution to ensure the detectability of impurities, the detector signal for the API may become saturated, preventing accurate determination of its peak area. In such cases, the sample must be diluted so that the API peak height falls within the linear dynamic range of the detector. However, this requires multiple analyses at different sample concentrations for the API and impurities, and the associated dilution steps can be labor-intensive. Nexera X4 is a next-generation UHPLC system that inherits the technologies established in Shimadzu’s Nexera series and delivers top-class analytical performance. The photodiode array detector SPD-M40 X4 achieves linearity up to 3 AU through improvements in the optical system, enabling reliable quantification over a wide concentration range from low to high levels. In this article, an example of simultaneous analysis and quantification of an API and impurities using Nexera X4 is presented.

March 2, 2026 GMT