Quality Consistency Evaluation of Eszopiclone Tablets

Objective To study the quality of Eszopiclone Tablets of the two domestic manufacturers,and research quality consistency evaluation with original study medicine. Methods The product description,identification,related substances,content,content uniformity were studied Reference to the SFDA Drug Standards. And investigate the Dissolution with Different dissolution conditions. Results the quality of Domestic listed Eszopiclone Tablets is in line with the SFDA Drug Standards; The dissolution characteristics of Domestic listed drug were similar to the Original study medicine in pH1. 0 and pH4. 5 Dissolution medium,and the dissolution characteristics of Domestic listed drug were different from the Original study medicine. Conclusion Domestic listed Eszopiclone Tablets and the Original study medicine are in line with the SFDA Drug Standards; The dissolution characteristics between Domestic listed Eszopiclone Tablets and the Original study medicine were Not completely consistent.