Quality Evaluation of Losartan Potassium Tablets Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.006
- VernacularTitle:基于国家药品抽检的氯沙坦钾片质量评价
- Author:
Lin PEI
1
;
Dazhong DING
;
Longhua YANG
;
Zhao YANG
;
Jialiang ZHU
Author Information
1. 青岛市食品药品检验研究院,国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
- Publication Type:Journal Article
- Keywords:
Losartan potassium tablets;
Quality evaluation;
Genotoxic impurities;
Moisture;
Nitrites
- From:
Herald of Medicine
2025;44(9):1405-1409
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality profile of losartan potassium tablets in China based on national drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and to provide evidence for improving quality standards along with feasible regulatory recommendations.Method A comprehensive evaluation was conducted on 196 sampled batches using statutory standards combined with exploratory studies,including tests for related substances,moisture,nitrites,nitrosamine,and azide genotoxic impurities.Results The compliance rate under statutory standards was 100%.However,exploratory analyses identified variations in moisture and nitrite levels among products,although genotoxic impurities and related substances were either undetectable or well below regulatory limits.Conclusions Losartan potassium tablets demonstrate satisfactory quality,though existing standards require further refinement by adding moisture and nitrite specifications.
