Discussion on Management Methods for National Drug Reference Standards based on the Hygroscopicity Study of Vitamin B12
Objective:To discuss the management methods for hygroscopic chemical reference standards based on the hygroscopicity study of vitamin B12,so as to improve and enhance the management of national drug standards substance.Methods:The hygroscopicity of vitamin B12 reference standard was analysed by dynamic water absorption method.Based on the analysis results,the management methods of hygroscopic national drug reference standards substance were discussed from each aspect.Results:When humidity changed at 20％-80％RH,the water adsorption of vitamin B12 continued to increase,which indedicated significant hygroscopicity.The sample lost 1.4％weight at RH 20％environment,and the change in sample quality significantly increased to 1.3％at RH 50％environment.Further DVS for this batch of reference standard in application area RH 25％to 45％,the sample lost 0.7％weight at RH 25％and increased 0.56％at RH 45％.Therefore,it was recommended that vitamin B12 reference standard should be rapidly weighed at RH 30％-40％.Conclusion:In order to comprehensively enhance the management and quality of national drugreference standards and provide guarantees for the implementation of drug quality standards and medication safety,corresponding management methods,which according to the hygroscopic chemical standards substance,should be developed for its characteristics in the stages of raw material screening,packaging,packages,labels and instructions,stability inspection and so on.
national drug reference standardsvitamin B12hygroscopicitydynamic vapor absorption analysismanagement methods
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NSTL
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