Development and Revision of the General Principles of Physical and Chemical Analysis in the Chinese Pharmacopoeia 2020 Edition Volume / 中国药学杂志

ABSTRACT

OBJECTIVE: To provide references for the correct understanding and accurate implementation of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 Edition volume . METHODSE The principles, processes, and main considerations of the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volume IV are introduced, and the content and main characteristics are summarized and analyzed. RESULTS: According to the goals and key tasks of the Chinese Pharmacopoeia 2020 edition, the principles of scientificity, versatility, operability, gradual and sustainable development, and harmonization with international standards, the physical and chemical analysis committee of the Chinese Pharmacopoeia commission carry out the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volume . Further expand the application of advanced and mature analytical techniques, strengthen the applicability of analytical methods and the development of the external pollution control methods for Chinese medicinal materials, and improve the harmonization of analytical techniques and impurity control requirements with international technical requirements. CONCLUSION: The physical and chemical analysis general chapters of Chinese Pharmacopoeia 2020 edition volume provide method and technical support to ensure the safety, effectiveness and controllable quality of China's pharmaceuticals, and play an important and positive role in encouraging the application of advanced analytical technology, strengthening drug regulatory measures, and enhancing the international influence of the Chinese Pharmacopoeia.