Abstract: Objective To evaluate the quality status of donepezil hydrochloride for providing reference for its production, quality control and supervision. Methods According to the general requirements of inspection program, the statutory methods combined with the exploratory studies were used to evaluate the quality condition of 140 batches of donepezil hydrochloride produced by 7 manufactures. Results All samples were inspected according to the executive standards, and the qualified rate was 100%. But there were some quality differences in related substances and assay among generic drugs, RLD (reference listed drug), and products passing the consistency evaluation. The legal standards were various with different test items and the methods and limits of standards were not uniformed. Conclusion The overall quality of donepezil hydrochloride was good, but there was still a gap between the quality level of the generic drug and the RLD. The current standard is basically feasible,but it still needs to be perfected to control the production process and improve the quality of preparations.

Key words: donepezil hydrochloride, drug random inspection, quality analysis, reference listed drug, generic drug, consistency evaluation