Simultaneous Analysis for Drug Purity Test and Quantitative Assay

User Benefits

- Two different analyses, such as purity tests and quantitative assays described in the pharmacopoeia, can be performed simultaneously on a single HPLC to increase the throughput of analytical work. - Creating a high speed analytical method that meets the system suitability prescribed in the monograph by modifying analytical conditions within the allowances described in USP <621> provides time reduction and solvent saving in HPLC analysis conforming to USP.

Introduction

The United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP) prescribe analyses with a variety of protocols, such as purity tests and quantitative assays, to ensure the quality of drug products. When such pharmacopoeias specify HPLC analyses, it often suggests multiple tests with different conditions depending on the purpose of the analyses, to be performed separately with multiple HPLCs. In this article, The high speed analytical methods for both purity test (related substances) and the quantitative assay of ibuprofen described in "USP43-NF38" were created conforming to USP General Chapter <621> Chromatography (hereafter, referred to as "USP <621>"), describing allowances for modifying analytical conditions. Then the high speed purity test and the high speed quantitative assay were executed with the Nexera Dual Injection System, simultaneous.

June 28, 2022 GMT