Interpretation of Scanning Electron Microscopy Method in Chinese Pharmacopoeia 2025 Edition

OBJECTIVE To interpret the new “scanning electron microscopy method” added in the Chinese Pharmacopoeia(ChP) 2025 Edition, so as to help the implementation of the standard and provide a scientific basis for drug testing.

METHODS By comparing the standards of pharmacopoeias from different countries, the overview of the addition and revision of the scanning electron microscopy method in ChP was introduced. The background, technical features, and key points of implementation of this method were systematically expounded. At the same time, specific applications of the method were discussed through practical cases of drug testing.

RESULTS The newly added scanning electron microscopy method in the ChP 2025 Edition provided a more accurate and efficient technical means for drug testing. This method could visually display the micro-morphology of the drug surface, accurately analyze the composition and elemental composition of the drug, and conduct crystallographic analysis, thereby effectively improving the accuracy and scientific nature of drug testing.

CONCLUSION The newly added scanning electron microscopy method in the ChP 2025 Edition has significant application value. It not only provides strong technical support for pharmaceutical quality control but also injects new vitality into the innovative development of pharmaceutical research and development.