Industry News

Xi’an DELI Biochemical Industry Co., Ltd. Product News: Betadex Sulfobutyl Ether Sodium

2024-10-24

Product Overview:


    Betadex Sulfobutyl Ether Sodium is a sodium salt formed by the alkylation of Betadex with 1,4-butanesulfonic acid lactone under alkaline conditions. As a highly water-soluble anionic derivative of Betadex, it can interact with drug molecules to form non-covalent complexes, enhancing drug stability, water solubility, and safety. This excipient also helps to reduce renal toxicity, mitigate drug-induced hemolysis, control drug release rates, and mask unpleasant odors.


U.S. Food and Drug Administration DMF: 034773

CAS NO: 128410-00-0

Molecular Formula: C42H70-nO35·(C4H8SO3Na)n

Grade: Injection grade

Specification Standard: USP/EP/Enterprise Standard

Available Specifications: 500g/Bag; 1kg/Bag; 10kg/Bag; 10kg/Drum

Application Area: Medicine



Other Relevant Information:


    Betadex Sulfobutyl Ether Sodium is an excipient widely used in various pharmaceutical formulations such as injectables, oral medications, nasal sprays, and eye drops. It has a particular affinity for nitrogen-containing drugs, making it highly effective for complexation. This excipient has been extensively used in injectable drugs such as Ziprasidone Mesylate, Voriconazole, Aripiprazole, Remdesivir, Posaconazole, Delafloxacin, and Carbamazepine.

    Originally developed by CyDex Pharmaceuticals in the 1990s, this anionic and highly water-soluble derivative of β-cyclodextrin is composed of various polymers with different degrees of substitution and isomeric structures. It forms non-covalent inclusion complexes with drug molecules, improving their stability, solubility, and safety. Compared to β-cyclodextrin, it offers better water solubility, lower hemolytic activity, and reduced nephrotoxicity, making it a promising excipient for various pharmaceutical applications.





Product Advantages:


1. Quality Advantage:

① Meets USP, EP standards.

② Low impurity levels and endotoxin limits, making it suitable for a broad range of formulations.

③ Can provide customized products with different pH levels and degrees of substitution according to client needs.

④ Dedicated production lines ensure stable supply with batch capacity of 2.5 tons and annual production capacity exceeding 300 tons.


2. Regulatory Advantage:

① Registered in major markets such as China, the U.S., and Europe:

② CN Registration Number: F20180000117 (Approval: A, with formulation review).

③ U.S. DMF Number: 034773 (Status: A).

④ HALAL certification and ISO 9001 certification.

⑤ Ongoing registration in other global markets.


    Betadex Sulfobutyl Ether Sodium has gained wide recognition in the pharmaceutical industry for its excellent performance and versatility. Xi’an DELI Biochemical Industry looks forward to further expanding its application and delivering high-quality solutions to clients worldwide.



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