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China/Asia On Demand
Journal Articles
Quality assessment of domestic itraconazole capsules
Pages: 508-511
Year: Issue:  6
Journal: Chinese Journal of Antibiotics

Abstract: Objective To evaluate the quality of domestic itraconazole capsules.Methods By researching on the original standard and the exploratory experiments including comparing the dissolution curves,related substances,and X-ray powder diffractions,the quality and the standard controllability of itraconazole capsules were evaluated.Results The differences in the dissolution curves of itraconazole capsules shows that the stability of domestic itraconazole capsules still needs to be improved.The original standard in the ChP 2010 edition is basically effective in item inspections,testing methods,and the standard limits,whereas the testing methods for determining dissolution and related substances need to be modified.Conclusion The quality of domestic itraconazole capsules is generally good.However,it is necessary to improve its standard for better quality control.
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