Quality analysis and evaluation of nifedipine tablets from different manufacturers and batches
Objective 25 batches of nifedipine tablets were collected for multi-item determination,and the quality of products from different manufacturers was analyzed and evaluated.Methods According to Chinese Pharmacopoeia,the properties,related substances,content uniformity,dissolution and content determination of products from different manufacturers were compared,and the results were statistically analyzed and evaluated.Results The test results of 25 batches were all in line with the standard of Chinese Pharmacopoeia,and the qualified rate was 100%,but there were great differences.Conclusion The quality of nifedipine tablets from different manufacturers is different,some manufacturers need to improve their control of related substance Impurity Ⅱ.
万方数据
维普
