Overview and Analysis of General Chapters (Appendices)of Physical and Chemical Testing Methods in Pharmacopoeias / 中国药学杂志

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.