Research Progress on Critical Quality Attribute of Estazolam Active Pharmaceutical Ingredients and Estazolam Tablets
Objective To provide a reference for the quality research of consistency evaluation of Eszolam Tablets.Methods The latest research progress on the critical quality attribute(CQA)of domestic estazolam active pharmaceutical ingredients(API)and Estazolam Tablets was searched.Based on the characteristics of the production process and risk assessment,the CQA indicators were determined,the control differences of CQA indicators in the domestic and foreign quality standards of estazolam API and Estazolam Tablets were compared,and the possible risks in the current quality standards were summarized.Results The current standard of eszolam API in the related substance items in the Chinese Pharmacopoeia(Edition 2020)lacked specific impurity control,and the production enterprises of eszolam API lacked research and control strategies for genotoxic impurities.The current standard of Estazolam Tablets in the Chinese Pharmacopoeia(Edition 2020)had weak distinguishability in dissolution conditions,and poor accuracy of UV method for dissolution amount,content uniformity,and content determination.The control strategy for impurities related to substances was unreasonable and could not reflect the actual quality differences of domestic Estazolam Tablets.After consistency evaluation,the registration quality standards significantly improved,mainly including chromatographic conditions of the related substances and significant differences in known impurity limits.Conclusion It is recommended that production enterprises that have not passed the consistency evaluation should focus on CQA indicators such as substances,impurity spectra,genotoxic impurities,dissolution rate,content uniformity,and content determination when conducting quality research on estazolam,and continuously improve the quality of products by optimizing product formulation and process design.Meanwhile,it is recommended to revise the quality standards for estazolam API and Estazolam Tablets in the Chinese Pharmacopoeia(Edition 2020)to meet the quality supervision requirements of marketed drugs and ensure the safety and effectiveness of medication.
万方数据
维普
