Comparison and Analysis of Visible Particle Inspection Methods in Domestic and International Pharmacopeias
Objective:This article aims to study the analysis methods of visible particles test in the major Pharmacopeias worldwide and to provide some suggestions and ideas for the upgrade of the visible particles test in the Chinese Pharmacopeia.Methods:Through reviewing the major Pharmacopeias worldwide,the definition of visible particles,the manual visual inspection,and the judgment standards of visible particles were analyzed and compared,and the similarities and differences of the major Pharmacopeias worldwide were summarized.Results:The Pharmacopeias worldwide were differences in the definition and judgment standard of visible particles,and there were differences in the requirements for detecting personnel,light sources,light intensity,inspection quantity,and specific operation methods of manual visual inspection.Different Pharmacopeias showed certain strengths and weaknesses,and the detection parameters were both complementary and constrained.Conclusion:It is suggested that the Chinese Pharmacopoeia should combine the advantages and disadvantages of major Pharmacopeias worldwide,meanwhile,based on the current situation of Chinese enterprises,to further improve the content of the visible particles test and ensure the quality of drugs and the safety of people's medication.
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