Objective:To introduce the problems of hygroscopic chemical reference substances in drug regulatory application and give suggestions,in order to provide reference for better application of national drug reference substances in drug regulation. Methods:Regulations related to pharmaceutical reference substances were expounded,and the problems encountered in the use were analyzed and the hygroscopic chemical reference substances by dynamic vapor absorption analysis (DVS) were studied. Suggestions from the aspects of standard implementation,instructions,packaging and storage,weighing and moisture determination were provided. Results and Conclusion:Chemical reference substances with hygroscopic properties are a relatively special type of reference standard. Due to their hygroscopic properties affecting the stability of measurement values,they has posed several problems and challenges to drug regulation. Through the achievements of research on hygroscopicity,the improvement of reference standard instructions,and the summary of practical work experience,all parties are working together to solve the problems and better improve the application of national reference substances,in order to ensure the effectiveness of drug regulation and the safety of drug.
关键词
药品监管/化学对照品/引湿性/动态水分吸附/国家药品标准物质
Key words
drug regulation/chemical reference substances/hygroscopicity/dynamic vapor absorption analysis/national drug reference substances
维普
万方数据