| Abstract:Objective: This article aims to study the Visible Particles Test in the major Pharmacopeias worldwide and to provide suggestions and ideas for improving the Visible Particles Test Chapter in the Chinese Pharmacopeia. Methods: Through reviewing the major Pharmacopeias worldwide, we analyzed and compared the definition of visible particles, the inspection method, the judgment of result, further summarized their similarities and differences.Results: Throughout the Pharmacopeias around the world, there are differences in the definition of visible particles and the judgment of results, which are mainly reflected in the requirements for detecting personnel, light sources, light intensity, number of tests, and specific operation methods. Different Pharmacopeias showed certain strengths and weaknesses, and the detection parameters are 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. |