Objective: To evaluate the quality of ambroxol hydrochloride oral solution. Methods: The 127 batches of ambroxol hydrochloride oral solutions were tested according to the statutory quality standards, antibacterial agent, sweetener, related substance and stability after opening of samples were studied based on inspected results within standard. Results: The qualified rate of all samples detected by the statutory quality standards was 100.0%. The results of exploratory research indicated that the types and dosage of bacteriostatic agent and sweetener were quite different among different enterprises, The impurity level of the enterprises were significantly different, and the results of determinated impurity B showed that 22% of the sample exceeded the proposed limit. Most of the samples had good stability after opening the bottle, but 7.9% of the samples were degraded to different degrees. Conclusion: At present, the overall quality of ambroxol hydrochloride oral solution is good, but there are still some suggestive quality and safety risks. The current standard should be improved and unified.
ZHANG Bing-hua, LIANG Ya-wei, WANG Xiao-liang, XI Zhi-fang, DENG Yu-long, NIU Long-qing
. Quality evaluation ambroxol hydrochloride oral solution*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(6)
: 1012
-1018
.
DOI: 10.16155/j.0254-1793.2023.06.12
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