Betadex Sulfobutyl Ether Sodium

 

Name	Betadex Sulfobutyl Ether Sodium
CAS No.	182410-00-0
Molecular Formula	C42H70-nO35 (C4H8O3SNa)n
Molecular Weight	1135+158n
Appearance	White powder, sweet, insipid and innocuous
Assay	95.0%-105.0%
Classification	Injection Grade
Quality Standard	USP/EP
DMF No.	030167

 

Molecular structuer:

 

 

Betadex Sulfobutyl Ether Sodium salt (SBECD) is a highly water-soluble anionic derivative of β-cyclodextrin. It is commonly used as a pharmaceutical excipient or complexing agent in the pharmaceutical industry.

SBECD acts as a solubilizer and stabilizer for drugs with low water solubility. By forming inclusion complexes with drug molecules, it can enhance the solubility, dissolution rate, and bioavailability of the drug. The sulfo-butyl ether group in SBECD carries a negative charge, which interacts with positively charged drug molecules, thereby improving their hydrophobicity and solubility. This, in turn, contributes to increased drug absorption, enhanced stability, and improved overall formulation characteristics. Furthermore, the anionic nature of SBECD enables it to form non-covalent complexes with drug molecules, thereby improving their stability, water solubility, and safety. It can also help reduce kidney toxicity, prevent drug-induced hemolysis, control drug release rates, and mask unpleasant odors or tastes associated with certain drugs.

 

 

The key index control is higher than the relevant quality standards

ITEMS	RESULTS
1,4-butane sultone	Not detected(＜0.01ppm)
4-hydroxybutane-1-sulfonic acid	Not detected(＜0.0005%)
Bis(4-sulfobutyl) ether disodium	Not detected(＜0.0005%)
Bacterial endotoxins	＜0.005EU/mg
Clarity of solution and color	30%(w/v) solution is clear and essentially free from particles of foreign matter.

 

Hemolysis is better than the innovator drug.

 

 

 

1.Stable product quality and high production capacity

2.Customizable according to requirements

3.Compliance with GMP standards

4.ISO certification attainment

 

 

 

 

Standard	USP
ITEMS	SPECIFICATION
Clarity of Solution	A 30%w/v solution in water is clear and essentially free from particles of foreign matter
Identification (IR)	Same absorption bands as USP betadex sulfobutyl ether sodium RS
Identification(Sodium)	Identify test are positive for Sodium
Identification(LC)	the retention time of the major peak of sample solution corresponds to the standard solution
Average Degree of Substitution	6.2-6.9
Water Solution pH	pH of 30%w/v solution in water is 4.0-6.8
Water Content	≤10.0%
β-Cyclodextrin Content	≤0.1%
Sodium Chloride	≤0.2%
1,4-butane sultone	≤0.5ppm
4-Hydroxybutane-1-Sulfonic Acid	≤0.09%
Disodium bis-(4-sulfobtyl) ether	≤0.05%
Assay	95.0%-105.0%
Bacterial Endotoxins	≤10EU/g
Microbiology
TAMC ( cfu/g)	≤100 cfu/g
TYMC ( cfu/g)	≤50 cfu/g
Escherichia Coli	Absence

 

 

 

Betadex sulfobutyl ether sodium (CAS NO. 182410-00-0) is a novel anionic, highly water-soluble cyclodextrin derivative that functions as a solubilizer, wetting agent, chelating agent (complexing agent), and masking agent for polyvalent compounds.

1. Pharmaceutical Applications: Betadex Sulfobutyl Ether Sodium is widely used in injectable, oral, nasal, and ophthalmic formulations. It exhibits exceptional affinity and inclusion capabilities for nitrogen-containing drugs.

2. Enhanced Drug Properties: It improves drug stability, solubility, and safety by forming non-covalent inclusion complexes with drug molecules.

3. Reduced Toxicity: It mitigates renal toxicity and minimizes drug-induced hemolysis.

4. Controlled Release: Enables sustained or extended drug release.

5. Taste Masking: Effectively conceals unpleasant drug tastes and odors, enhancing patient compliance.

6. Excipient Function: As a pharmaceutical excipient, it provides optimal viscosity and flowability, ensuring uniform drug distribution in formulations.

 

 

- Inner Packaging: PE bag + aluminum foil bag.

- Storage: Store in tightly sealed containers, protected from moisture.

- Labeling: Customizable per customer requirements.

- Outer Packaging: Drum packaging.

- Available Sizes: 100g/bag, 1kg/bag, 2kg/bag, 10kg/bag or drum, 20kg/bag or drum.

 

 

 

 

 

 

 

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