Study on Related Substances in Clozapine / 中国药师

ABSTRACT

Objective: To study the related substances in clozapine and its preparations. Methods:Comparative analysis was adopted according to the method respectively described in Chinese pharmacopoeia and United States pharmacopoeia. Results:The impurity profile of clozapine from domestic and abroad was basically the same, and that of clozapine and its preparations was also basically the same. The method in United States pharmacopoeia was better than that in Chinese pharmacopoeia in terms of in terms of separation of the impurities. Conclusion: The current legal inspection standard for the related substances in clozapine described in Chinese pharmacopoeia should be improved.