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 Ⅳ. METHODSE The pinciples, 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 Ⅳ. 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 Ⅳ 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.
徐昕怡, 宋宗华, 贺浪冲, 杨昭鹏. 2020年版《中国药典》四部理化分析通则的增修订与浅析[J]. 中国药学杂志, 2020, 55(14): 1172-1176.
XU Xin-yi, SONG Zong-hua, HE Lang-chong, YANG Zhao-peng. Development and Revision of the General Principles of Physical and Chemical Analysis in the Chinese Pharmacopoeia 2020 Edition Volume Ⅳ. Chinese Pharmaceutical Journal, 2020, 55(14): 1172-1176.
HONG X X, XU H Y, SHANG Y, et al. Brief introduction of Chinese Pharmacopoeia 2015 edition volume Ⅳ [J]. Chin Pharm J(中国药学杂志), 2015, 50(20):1782-1786.
[2]
XU X X, XU H Y, JIN G M, et al. Overview and analysis of general chapters (appendices) of physical and chemical testing methods in pharmacopoeias [J]. Chin Pharm J(中国药学杂志), 2018,53(15):1323-1332.
[3]
JIANG X P, HONG X X. Introduction of general chapters of Chinese Pharmacopoeia 2015 edition going into the new normal developing [J]. Chin Pharm J(中国药学杂志), 2015, 50(20):1787-1789.
[4]
Chinese Pharmacopoeia Commission. Announcement on the release of the outline of the preparation of the 2020 edition of the Chinese Pharmacopoeia [EB/OL]. (2018-01-30) [2019-12-21]. http://www. chp. org. cn/view/ff8080815e0d584f01614 671d79d5753?a=tz.
[5]
XU X X, XU H Y, ZHANG Q M, et al. Introduction of ICH Q4 guideline [J]. Chin J Pharm(中国医药工业杂志), 2019,50(3):349-354,358.
[6]
XU X X, LIU Z, ZHANG Z, et al. Review of the Chinese Pharmacopoeia tablet friability test revision history and prospects for harmonization with ICH [J]. Chin Pharm(中国药师), 2019, 22(6):1138-1140.
[7]
ZHANG Z, XU X X, LIU Z, et al. Comparative assessment of the differences between Chinese Pharmacopoeia and ICH Q4B detection methods [J]. Chin Food Drug Admin Mag(中国食品药品监管), 2019,12:24-33.
[8]
Chinese Pharmacopoeia Commission. Adoption of the ICH Q4 Pharmacopoeial Test Method Workshop was held in Beijing [EB/OL]. (2018-11-16) [2019-12-21]. http://wp.chp.org.cn/front/chpint/en/.
[9]
XU X X, LIU Z, HONG X X. Application of X-ray fluorescence spectrometry in analysis of drug elemental impurities [J]. Pharm Clin Res(药学与临床研究), 2019,27(5):368-370.
[10]
USP 40 Vol Ⅳ. General Chapters: <735> X-Ray Fluorescence Spectrometry, <1226> Verification of Compendial Procedures, <1224> Transfer of Analytical Procedures, <921> Water Determination, <621> Chromatography[S]. 2017: 15-620, 1786-1787, 1778-1780, 815-820, 508-520.
[11]
EP 9.0. General Chapters: 2.2.37 X-Ray Fluorescence Spectrometry, 2.9.26 Specific Surface Area by Gas Adsorption, 2.2.42 Density of Solids, 2.9.3 Dissolution Test for Solid Dosage Forms, 2.2.5 Relative Density, 2.5.32 Water-micro Determination, 2.2.48 Raman Spectroscopy[S]. 2017: 61, 344-347, 70-71, 302-309, 25-26, 172, 86-88.
[12]
BP 2019. Appendix II F: X-Ray Fluorescence Spectrometry[S]. 2019: V-A198-V-A199.
[13]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 7(R2) [EB/OL]. (2010-11-11) [2019-12-21]. https://database.ich.org/sites/d2.2.37 efault/files/Q4B_annex_7_R2_Annex.pdf.
[14]
GB/T 19587-2004, Determination of the specific surface area of solids by gas adsorption using the BET method(中华人民共和国标准气体吸附BET法测定固态物质比表面积)[S]. 2004: 1-10.
[15]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 13 [EB/OL]. (2012-06-07) [2019-12-21]. https://database.ich.org/sites/default/files/Q4B_Annex_13_Annex.pdf.
[16]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology Q2(R1) [EB/OL]. (2005-11) [2019-12-21]. https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf.
[17]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Impurities for Residual Solvents Q3C(R6) [EB/OL]. (2016-10-20) [2019-12-21]. https://database.ich.org/sites/default/files/Q3C-R6_Guideline_ErrorCorrection_2019_0410_0.pdf.
[18]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Impurities in New Drug Substances Q3A(R2) [EB/OL]. (2006-10-25) [2019-12-21]. https://database.ich.org/sites/default/files/Q3A_R2__Guideline.pdf.
[19]
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Impurities in New Drug Products Q3B(R2) [EB/OL]. (2006-06-02) [2019-12-21]. https://database.ich.org/sites/default/files/Q3B_R2__Guideline.pdf.
2020, Vol. 55 
