The Pharmacopoeia of the People’s Republic of China 2015 Edition (hereinafter referred to as the “Chinese Pharmacopoeia”) is the 10th edition of Chinese Pharmacopoeia, which was approved by the China Food and Drug Administration (CFDA) on June 5, 2015 and came into effect as of December 1, 2015.
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Highlights & Features
- 5,608 total monographs-including 1,082 new monographs and 1,134 revisions
- Increased significantly the number of products, especially for pharmaceutical excipients
- Established pharmacopoeia standard system, integrated the common appendices and renamed the original appendices into General Chapters
- Improved further on drug safety assurance, and drug efficacy control
- Expanded the application of modern analytical technology
- Strengthened guiding effect of pharmacopoeia
- Drafted in a more public, transparent, standardized and orderly manner
Published in Four Volumes
- VolumeⅠ: 2,598 monographs of medicinal materials and the prepared slices of Chinese crude drugs, vegetable, oil fat and extracts, single-item preparations, etc., including 440 new monographs, 517 revisions and 7 rejections.
- Volume Ⅱ: 2,603 monographs of chemical drugs, antibiotics, biochemical drugs and radioactive drugs including 492 new monographs, 415 revisions and 28 rejections．
- Volume Ⅲ: 137 biologics, including 13 new monographs, 105 revisions and 6 rejections.
- Volume Ⅳ: 270 monographs of pharmaceutical excipients, including 137 new monographs, 97 revisions and two rejections. A total of 317 general chapters, including 38 general requirements for preparations, 240 testing methods, 30 guidelines and 9 standard substances and testing solutions and reagents.