Organic Impurity Analysis of Cetirizine Hydrochloride Drug Material Following USP Monograph

User Benefits

- Two procedures (1 and 2) for organic impurities analysis of cetirizine hydrochloride following USP 41 monograph were performed on Shimadzu i-Series LC-2050 HPLC system. - The results of testing solutions of cetirizine hydrochloride drug substance meet the suitability test requirements and show highly-sensitive HPLC analysis feature in the impurity profiling analysis.

Introduction

The profiling analysis of impurities in drug products is essential for ensuring product quality and consumer safety. Cetirizine is a non-sedating antihistamine, which is classified as a second-generation antihistamine. According to the USP 41 monograph for the organic impurity analysis of cetirizine hydrochloride, there are two procedures which can be applied for different types of impurities analysis. In this application note, these two analysis procedures were performed on Shimadzu i- series LC-2050 HPLC system for profiling analysis of organic impurities in cetirizine hydrochloride drug substance.

October 30, 2025 GMT