Objective To evaluate the quality of ampicillin sodium for injection.Methods The quality of this product was assessed by conducting tests on 95 batches of samples using both the statutory standard procedures and exploratory research methods.Additionally,the product's quality was reviewed by comparing its results with three national random drug testing outcomes over a period of time.Results According to the statutory standards,95 batches of samples all met the requirements.There were obvious differences in alkalinity,related substances,water and the content of samples between freeze-drying and solvent crystallization processes.The alkalinity and content calculated by anhydrous substance of freeze-dried products were relatively low.The impurities and moisture of freeze-drying products were relatively high.Under the condition of the accelerated test,the exploratory study showed that the color of raw materials with the freeze-drying process was deepened and the impurities increased,with the passage of time.However,the color and impurity of the products changed little in the process of solvent crystallization.Conclusions The quality of ampicillin sodium for injection was generally of good quality.The quality of products using the solvent crystallization process as the raw material was relatively better.The production process of the raw material was the main factor affecting the quality of the product.
关键词
注射用氨苄西林钠/质量评价/生产工艺
Key words
Ampicillin sodium for injection/Quality evaluation/Production process
维普
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