Impurity Analysis in Pharmaceutical Products with the Advanced Photodiode Array Detector SPD-M40

Introduction

Impurities in pharmaceuticals must be appropriately controlled to ensure product safety. The ICH guidelines on impurities in pharmaceutical substances and impurities in drug products have established specific thresholds for impurities. If the content of impurity in pharmaceuticals is more than 0.1 %, it is necessary to identify its structure, perform the safety evaluation and report to the regulatory authorities. Therefore, the accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing. The following procedure is commonly used to measure the concentration of impurities in pharmaceutical products using area percentage normalization: prepare and analyze the standard solution at a concentration such that the height of the main peak will be within the linear range of the detector, then analyze multiple dilutions of the sample. Since the new photodiode array detector SPD-M40 has completely eliminated the effects of stray light during detection, it not only provides a wide dynamic range (linearity up to 2.5 AU as a specification value, typical value is more than 2.5 AU) but also achieves low noise and high sensitivity. Moreover, the SPD-M40 has little fluctuation in its baseline thanks to Advanced TC-Optics (triple temperature control of the cell, light source, and optical system), making it ideal for analyzing trace impurities in pharmaceuticals.

April 5, 2019 GMT