Objective:Clindamycin metronidazole liniment was changed from the supplier of raw material metronidazole.In order to evaluate the effect of the change of raw material supplier on the quality of the preparation,the quality of raw material metronidazole was compared before and after the change.The impurity of preparation before and after the change was compared.The quality stability of preparation products before and after the change was studied.Methods:The crystal type,particle size distribution,impurities and content of metronidazole were studied by powder X-ray diffraction,laser particle size analysis and high performance liquid chromatography.The impurities and quality of the preparation products were compared and the stability test was carried out.Results:The quality comparison of the supplier's raw material metronidazole before and after the change showed that it was the same crystalline raw material,the particle size distribution was basically the same,and the impurity and content were not significantly different.There was no significant difference in impurity and quality before and after metronidazole modification.After the change of metronidazole,the product stability comparison test showed that the test results had no significant change and the quality was stable.Conclusion:When the supplier of raw material metronidazole is changed,there is no significant difference in the quality of raw material metronidazole and no adverse impact on product quality.
Clindamycin metronidazole linimentMetronidazole raw material changeHigh performance liquid chromatographyUltraviolet-visible spectrophotometry
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NSTL
万方数据
