摘要
Abstract
Objective To analyze the precipitate source of Dextran 40 Sodium Chloride Injection and find the factors affecting,propose control measures. Methods By analyzing the factors in the nature of the product precipitate,and com-bined test,production experience,to determine the control measures. Results Dextran 40 Sodium Chloride Injection precip-itate was crystallized dextran 40;API product quality,transport and storage conditions on the Dextran 40 Sodium Chloride Injection precipitate had a direct relationship. Conclusion By improving the quality of API and to ensure that transport and storage conditions can reduce precipitation crystallization,and revise the package insert to identify the approach of crystal clear.关键词
右旋糖酐40氯化钠注射液/析出/结晶/因素/控制措施Key words
Dextran 40 Sodium Chloride Injection/Precipitation/Crystallization/Factors/Control measures分类
医药卫生
