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The Betadex Sulfobutyl Ether Sodium obtained CEP certificate

日期:2022-06-22

  Recently,we received the European Pharmacopoeia certification(hereinafter referred to as "CEP certificate")for the suitability of Betadex Sulfobutyl Ether Sodium as a pharmaceutical excipient, which issued by the European Directorate for Quality Medicines (EDQM). Zibo Qianhui is the only company in the world to obtain the CEP certificate of Betadex Sulfobutyl Ether Sodium for pharmaceutical excipients. The certificate indicates that the excipient meets the quality requirements of the European Pharmacopoeia, shows the recognition and affirmation of the excipient quality in the European standard market, and emblems that it can be sold in the European market and other standard markets that recognize CEP certificate, which has a positive impact on the company's further expansion of the international market.

  Betadex Sulfobutyl Ether Sodium is a new kind of pharmaceutical excipient, which can form inclusion complex with guest molecules (such as API), and then change the physical properties of guest molecules.Because of its good safety, it has been used as injection excipients.At present, the use of Betadex Sulfobutyl Ether Sodium as an excipient is a new way to solve the solubility of insoluble drugs, such as Desivir, Posaconazole, voriconazole and so on.It can be predicted that in the future, Betadex Sulfobutyl Ether Sodium can partially replace the oil solvent, surfactant and other excipients used in injection.At the same time, because of inclusion, Betadex Sulfobutyl Ether Sodium can also be used as a stabilizer, odor mask, complexing agent and so on.

 Qianhui biological has always attached importance to product quality, production process strictly comply with the requirements of GMP, and is committed to providing supplementary products to meet customer needs.The Betadex Sulfobutyl Ether Sodium have been registered in China CDE,The United States FDA, The European Directorate for the Quality of Medicines (EDQM).The product quality meets the United States pharmacopoeia and European pharmacopoeia.Regardless of product quality or production capacity, Qianhui biology has developed into the main base of Betadex Sulfobutyl Ether Sodium in the world.

 
 

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