ABSTRACT
The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.
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.
ABSTRACT
OBJECTIVE: To provide reference for introducing new methods and technologies to the physical and chemical testing methods general chapters in Chinese Pharmacopoeia Volume . METHODS: By reviewing the general chapters of drug physical and chemical testing methods (appendices)in the new editions of European, US, Japanese and British Pharmacopoeias, the harmonization results of the Pharmacopoeia Discussion Group (PDG)and the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the authors summarized the overview and new, revised and harmonized texts of physical and chemical testing methods, and made a preliminary comparison with the related testing methods in Chinese Pharmacopoeia (2015 edition) Volume . RESULTS: The new and revised text on the physical and chemical testing methods in the new editions of European, US, Japanese and British Pharmacopoeias are mainly concentrated in elements impurities, spectrometry and chemometrics. Chinese Pharmacopoeia can learn from the technology of identification tests, spectrometry and chromatography, impurities analysis and functionality-related characteristics of pharmaceutical excipients. CONCLUSION: Chinese Pharmacopoeia should be based on the actual level of China's pharmaceutical industry, follow the principles of progressive and sustainable development, introducing new drug testing technologies and methods to strengthen the quality control of drugs and improve drug controllability.