Quality Evaluation of Propranolol Hydrochloride Tablets Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.004
- VernacularTitle:基于国家药品抽检的盐酸普萘洛尔片质量评价
- Author:
Li LU
1
;
Fangxian SHAO
;
Hui XU
;
Chaoyu HUANG
;
Jialiang ZHU
;
Fei YAN
;
Rui LI
Author Information
1. 江苏省药品监督检验研究院,南京 210019;国家药品监督管理局化学药品杂质谱重点实验室,南京 210019
- Publication Type:Journal Article
- Keywords:
Propranolol hydrochloride tablets;
Quality evaluation;
Related substances;
Nitrosamine impurities
- From:
Herald of Medicine
2025;44(9):1390-1400
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product.Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed.Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects.Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
