Description

Betadex Sulfobutyl Ether Sodium is a chemically modified cyclodextrin derivative, specifically a sulfobutyl ether derivative of β-cyclodextrin sodium salt. This compound is a critical pharmaceutical excipient valued for its superior solubility and ability to form stable inclusion complexes with poorly water-soluble active ingredients. It is primarily needed by formulation scientists and manufacturers in the global pharmaceutical industry for parenteral and oral drug delivery systems, as well as by researchers in analytical chemistry and biotechnology.

Application

• Solubility Enhancement Agent: Widely used to improve the aqueous solubility, stability, and bioavailability of poorly soluble active pharmaceutical ingredients (APIs) in injectable and oral formulations.
• Drug Delivery Systems: A key component in the formulation of complex parenteral drugs, including cytotoxic agents and anesthetics, where it acts as a safe and effective solubilizer.
• Analytical Chemistry: Employed as a chiral selector in capillary electrophoresis (CE) and other separation techniques for the resolution of enantiomers.
• Stabilizing Excipient: Used to prevent the degradation or precipitation of sensitive drug molecules in solution, enhancing shelf-life.
• Biotechnology & Research: Utilized in biochemical research for protein stabilization, enzyme activity studies, and as a tool for membrane disruption.
• Cosmetic & Personal Care: Incorporated into high-end cosmetic formulations to enhance the stability and delivery of active compounds.

Basic Information

Product Name	Betadex Sulfobutyl Ether Sodium
CAS No.	182410-00-0
Molecular Formula	C42H70O35(C4H8SO3Na)n
Molecular Weight	~2163 g/mol (Average, n~6.5)
Synonyms	Sulfobutylether β-Cyclodextrin Sodium Salt; SBE-β-CD; Captisol®; SBECD; Sulfobutyl Ether β-Cyclodextrin Sodium; Betadex Sulfobutyl Ether Sodium Salt; 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(carboxymethyl)heptakis-(deoxy-6-sulfo)cyclomaltoheptaose Sodium Salt
EINECS	Contact for details

Quality Control

Our Betadex Sulfobutyl Ether Sodium is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure compliance with relevant pharmaceutical standards, including in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing key parameters such as assay, degree of substitution, impurity profile, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	≥ 98.0%
Degree of Substitution (NMR/Titration)	6.0 - 7.0
Water Content (KF)	≤ 10.0 %
Residue on Ignition	≤ 1.0 %
Heavy Metals	≤ 10 ppm
Residual Solvents (GC)	Meets ICH Q3C limits
Bacterial Endotoxins	< 20.0 EU/g (for parenteral grade)
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.