June 1, 2021,Shandong Binzhou Zhiyuan Biotechnology Co., Ltd. was invited to participate in the online seminar on the pharmacopoeial standard of betadex sulfobutyl ether sodium initiated by the Institute for the Control of Pharmaceutical Excipients and Packaging Materials of the China Food and Drug Control Institute with the participation of the National Pharmacopoeia Committee meeting.
Our company’s previously mentioned opinions on residual solvents, average substitution degree and impurity content determination have been recognized by experts. At this meeting, our company's suggestion that the product storage method should be changed to "shading, sealing, and storing in a dry place" was also affirmed by the participating experts.
Xiao Xinyue, member of the National Committee of the Chinese People's Political Consultative Conference and director of the Pharmaceutical Excipients and Packaging Materials Inspection Institute of China Food and Drug Control Institute, spoke highly of this seminar. Xiao Xinyue mentioned that the improvement of the quality standard of sulfobutyl beta cyclodextrin sodium will continue to extend this way in the future, that is, the way that the Pharmacopoeia Commission has always advocated, government-led, business entities, and social participation to jointly form a national standard. The Chinese Pharmacopoeia currently does not include sulfobutyl beta cyclodextrin sodium, and all manufacturers are currently adopting their own filed quality standards that are in line with international standards. The formulation of the national quality standard for sulfobutyl beta cyclodextrin sodium is exactly what we are concerned about and expect to do now. I hope that under the unified leadership of the Pharmacopoeia Commission, the team members will actively participate in the formation of our national quality standards and jointly improve the quality of sulfobutyl beta cyclodextrin sodium. This is the common wish of all of us.
Shandong Binzhou Zhiyuan Biological Technology Co., Ltd. is a high-tech pharmaceutical excipient manufacturer specializing in the application, production and innovation of cyclodextrin and its derivatives. On this basis, through the cooperation of production, education and research with first-class universities such as Nankai University, Fudan University, Shandong University, etc., the focus is on the application and development of cyclodextrin derivatives and cyclodextrin inclusion compounds. Among them, sulfobutyl beta cyclodextrin The pharmaceutical performance development project of refined sodium process optimization and related preparations was shortlisted for the key R&D project of the Ministry of Science and Technology "Technology Boosts Economy 2020". The company attaches great importance to R&D investment, innovation-driven development, and takes optimizing process and new product development as the starting point to promote technological progress and product upgrades in the industry to improve the quality of domestic cyclodextrin technology and the core competitiveness of the company.
The invitation to participate in the formulation of the pharmacopoeial quality standard of sulfobutyl beta cyclodextrin sodium is an affirmation of Zhiyuan Bio's innovative exploration in the field of cyclodextrin derivatives and highlights the important position of Zhiyuan Bio in this field. Zhiyuan Bio will wholeheartedly bring high-quality products and a full set of application solutions to all customers.