Objective: To investigate the hygroscopicity related problems that need to be addressed in the research and development of strong hygroscopic acarbose reference substance. Methods: Dynamic vapor absorption analysis (DVS) was applied to study on the hygroscopicity of acarbose reference substance. During the analysis with DVS, the temperature was set at 25 ℃, the N2 gas flow rate was 200 mL·min-1, and the relative humidity changes and time were regulated and controlled in program. Results: The hygroscopicity of acarbose reference substance in the present material process has been weakened compared to the early batch. Raw materials of acarbose reference substance with 3.5% water content was recommended, and it was recommended to complete the weighing process within 10 minutes in the quality control laboratory with the ambient humidity not to exceed RH45%. Conclusion: The hygroscopicity was affected by material process, water content and other ambient conditions. Further researches and precautions should be taken when dealing with strong hygroscopic reference substances.
LIU Yi, GUO Xian-hui, QIN Lin, YAN Jing, CHEN Hua
. Study on the hygroscopicity of national reference substance of acarbose*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(8)
: 1429
-1434
.
DOI: 10.16155/j.0254-1793.2023.08.20
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