The 2015 edition of the Chinese Pharmacopoeia was officially implemented on December 1, 2015. One of the main changes from previous edition was the more prominent role of the pharmaceutical excipients in formulation. There has been a substantial increase number of pharmaceutical excipient monographs, and the control for safety of pharmaceutical excipients are more stringent. In addition, testing methods have improved further and the overall standards level has significantly improved.

Chinese Pharmacopoeia Commission organized the relevant institutions for drug control and research all over the country to translate the pharmaceutical excipient standards of the current versions of the United States, European, and Japanese Pharmacopoeia to compile a Handbook of Standard Comparison of Pharmaceutical Excipients in Pharmacopoeias in order to fully demonstrate the level of development of pharmaceutical excipients, understand the standards of current pharmaceutical excipients, analyze the similarities and differences between domestic and foreign pharmaceutical excipient standards, conduct in-depth research on pharmaceutical excipients, narrow the gap between foreign pharmaceutical excipient standards, and promote the healthy development of pharmaceutical excipients industry in China.

The resultant book includes 1,182 varieties of pharmaceutical excipient standards, including 132 monographs from the Chinese Pharmacopoeia 2010 edition, 270 monographs from the 2015 edition, 516 from the 38th edition of the United States Pharmacopoeia, 277 from the 8.5th edition of the European Pharmacopoeia, and 133 from the 16th edition of the Japanese Pharmacopoeia. Related information and tests on pharmaceutical excipient standards were compared one by one, and clear differences between quality controls, test methods, and test limits of each national pharmaceutical excipient standards were observed. It provides a valuable reference guide for domestic and foreign medicines and medicinal materials development and production. It can also provide users and regulatory authorities a comprehensive understanding of the standards of each national pharmaceutical excipient and the difference between each national standard.

This handbook includes rich content, detailed analyses, and meticulous comparisons. For the convenience of the reader, digital software in the Chinese and English languages was also developed simultaneously, including Chinese and English versions of each national pharmaceutical excipient standards comparison. Due to the rapid development of domestic and foreign pharmaceutical excipients, the Chinese Pharmacopoeia Commission will closely follow development trends of domestic and foreign pharmaceutical excipient technologies and standards and continuously update the information of each national pharmaceutical excipient standard in order to keep the industry aware of the latest revisions. It will play an important role in facilitating future coordination and cooperation between international pharmacopoeia, which will further promote the development of international and domestic trade of pharmaceutical excipients.

Chinese Pharmacopoeia Commission will also take the online version of Handbook of Standard Comparison of Pharmaceutical Excipients in Pharmacopoeias as basis and use digital and information technology to speed up the construction of the platform for drug standards information service in order to provide more services that are automatically comparing each national pharmaceutical standards and analyzing quality standards. Readers can upgrade the electronic version of the related standards information according to permissions.

The authors would like to express heartfelt thanks to National Institutes for Food and Drug Control, Guangdong Institute for Drug Control, Jiangsu Institute for Food and Drug Control, Shandong Institute for Food and Drug Control, Hunan Institute for Food and Drug Control, China Pharmaceutical University, International Pharmaceutical Excipients Council (China), and Chemmind Technologies (Beijing) Co., Ltd. for offering support and participating in the preparation of this book.

Due to a limited level of experience and time constraints, oversights in the content of this book are inevitable. In this case, readers are encouraged to offer criticism and suggestions.

Editor
Chinese Pharmacopoeia Commission
February, 2016

II. The copyright of this software (including but not limited to general notices, monographs, appendices etc.) is owned by the Chinese Pharmacopoeia Commission.

III. Literature citation format: Chinese Pharmacopoeia Commissions. Handbook of Standard Comparison of Pharmaceutical Excipients in Pharmacopoeias. (Digital Edition) [M/CD], Beijing: China Medical Science Press. 2016.

©2015-2016 Chinese Pharmacopoeia Commission. All Rights Reserved. Any distribution, reproduction or duplication of this publication in part or in whole without written permission is expressly prohibited, and whoever violates this term shall be held for legal responsibilities.

II. In case of any discrepancy between this Handbook of Standard Comparison of Pharmaceutical Excipients in Pharmacopoeias (Digital Edition) and the printed edition of Chinese Pharmacopoeia, the latter shall prevail.

III. The Chinese Pharmacopoeia Commission reserves the right on the final interpretation of The Handbook of Standard Comparison of Pharmaceutical Excipients in Pharmacopoeias（Digital Edition）.

IV. Users who install and use this software shall be deemed as having accepted the terms and conditions of the end-user license agreement (EULA) covering the above copyright statement and disclaimer. If you do not agree with these terms, please do not install and use this software.

Shandong Institute for Food and Drug Control, Hunan Institute for Food and Drug Control, China Pharmaceutical University, International Pharmaceutical Excipients Council (China), and Chemmind Technologies (Beijing) Co., Ltd. for offering support and participating in the preparation of this book.

Chinese Pharmacopoeia Commission