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More Than 300 Varieties Of Pharmaceutical Excipient Recorded In 2015 Version Chinese Pharmacopoeia
Nov 02, 2018

June 03, 2014 By

Tu Jiasheng, a member of Chinese Pharmacopoeia Commission and a professor of China Pharmaceutical University, told to the reporter that, “There are about 543 varieties of pharmaceutical excipient currently used in our country and 2010 version Chinese Pharmacopoeia only recorded 132 varieties, only accounting 24.31% of the total number.” The revision work of 2015 version Chinese Pharmacopoeia has currently entered ending stage: therein, there are 380 tasks formulated in the revision work of pharmaceutical excipient texts and it is estimated that the pharmaceutical excipients finally recorded in the new edition pharmacopoeia will reach more than 300 varieties and include the excipients for TCM processing for the first time.

Sun Huimin, head of the Institutes for Control of Packaging Material and Pharmaceutical Excipient in National Institutes for Food and Drug Control, pointed out that the 2015 version Chinese Pharmacopoeia would be divided into 4 volumes, respectively being the TCM, chemical, biological product and excipient. “The pharmaceutical excipients will be in an individual volume: reference substances of pharmaceutical excipients will be greatly increased beside their variety quantity.”

The commonly used excipients for injection, including polysorbate 80, propylene glycol, poloxamer 188 and PEG (300/400), as well as the quality standard for injection of cremophor el (EL35) are planned to be added in the new edition pharmacopoeia. Currently the new edition has been completed the draft and reviewed; and has been discussed, modified and publicly notified by the specialized committee.

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