Product Description

Xi'an Deli Biochemical Industry Co.,Ltd. Is a high-tech enterprise specializing in research & development, production & sales of cyclodextrin and its derivatives. Since its establishment on August 27, 1999,the company has been adhering to the quality Policy of "focusing on accessories, quality first, sincere service, striving for first-class". After more than 20 years of hard work and development, the company currently has products DELI Brand Hydroxypropyl Betadex, DELI Brand Betadex Sulfobutyl Ether Sodium. The above products have been registered and filed with the FDA.

Wholesale Sulfobutylether-β-Cyclodextrin sodium salt CAS 182410-00-0 made in China from DELI. Our factory is a famous Sulfobutylether-β-Cyclodextrin sodium salt CAS 182410-00-0 manufacturers and suppliers in China. We will provide free sample. Our products are in stock. Welcome to buy our bulk products.

Sulfobutylether-β-Cyclodextrin sodium salt CAS 182410-00-0 has been used in injection, oral, nasal and eye medicines. It has a special affinity and inclusion for nitrogen drugs. Increase the drug's stability ,solubility ,safety (Include drug molecules to form non-covalent). Reduce renal toxicity, ease drug hemolysis. Sulfobutyl Ether Beta Cyclodextrin Sodium also can control the drug release rate, cover the bad smell.

Sulfobutylether Beta Cyclodextrin Sodium Salt CAS No. 182410-00-0

Product Overview

Sulfobutylether Beta Cyclodextrin Sodium Salt (SBECD) is a highly water-soluble, anionic β-cyclodextrin derivative developed as a pharmaceutical excipient for injectable drug delivery systems. By forming non-covalent inclusion complexes with active pharmaceutical ingredients (APIs), SBECD significantly improves solubility, stability, and formulation safety of poorly water-soluble drugs.

With excellent biocompatibility, low hemolytic potential, and controlled toxicity, SBECD is widely used in parenteral formulations for critical therapeutic areas including antiviral, antifungal, oncology, and cardiovascular medicines.

Description and Solubility/ see details in the USP Monograph	White to off-white,amorphous powder.Freely soluble in water;sparingly soluble in methanol;practically insoluble in ethanol,in n-hexane,in 1-butanol,in acetonitrile,in 2-propanol,and in ethylacetate
Identification A/IR; USP<197K>	Complies with SBECD reference
Identification B/(Assay method)HPLC; USP<621>	tR of the major peak complies with SBECD reference
Identification C/CE; USP<1053>	It meets the requirements of the test for Average Degree of Substitution.
Identification D/USP<191>	Positive test for sodium
Assay/HPLC;USP<621>	95.0%-105.0% on the anhydrous basis
Limit of Beta Cyclodextrin(Betadex)/IC; USP<621>;USP<1065>	NMT 0.1%
Limit of 1,4-Butane Sultone /GC;USP<621>,	NMT 0.5ppm
Limit of Sodium chloride /IC; USP<621>;USP<1065>	NMT 0.2%
Limit of 4-Hydroxybutane-1-sulfonic acid /IC;USP<621>;USP<1065>	NMT 0.09%
Limit of Bis(4-sulfobutyl) ether disodium /IC;USP<621>;USP<1065>	NMT 0.05%
Bacterial Endotoxins Test/USP<85>	≤10EU/g
Microbial Enumeration Tests/USP<61>	TAMC≤100cfu/g TYMC≤50 cfu/g
Tests for Specified Microorganisms/USP<62>	Absence of Escherichia Coli/1g
Clarity of Solution(30%,w/v)/visual;see details in the USP Monograph	The solution is clear, and essentially free from particles of foreign matter.
Average Degree of Substitution [DS]/CE;USP<1053>	6.2-6.9

Chemical & Functional Characteristics

Anionic β-cyclodextrin derivative
Betadex substituted with sulfobutyl ether groups
Highly soluble in water
Forms stable and reversible inclusion complexes
Functions as solubilizer, stabilizer, and release-rate modulator

Key Benefits

Significantly enhances aqueous solubility of poorly soluble APIs
Improves chemical and physical stability of injectable formulations
Reduces renal toxicity compared with traditional solubilizing agents
Minimizes hemolysis and injection-site irritation
Enables controlled drug release and consistent bioavailability
Masks unpleasant odor or taste of APIs when applicable
Suitable for repeated parenteral administration

Pharmaceutical Applications

Sulfobutylether Beta Cyclodextrin Sodium Salt is primarily used in injectable and parenteral dosage forms, including:

Intravenous (IV) injections
Intramuscular (IM) injections
Subcutaneous injections
Ophthalmic injectable and solution formulations
Specialized parenteral drug delivery systems

Main therapeutic areas: antifungal, antiviral, oncology, cardiovascular medicines.

Marketed Drug Applications

SBECD has been successfully applied in several commercially marketed injectable products, demonstrating its proven clinical performance:

Remdesivir Injection
Posaconazole Injection
Voriconazole Injection
Melphalan Hydrochloride for Injection
Ziprasidone Mesylate Injection

Product Specifications

Appearance: White to off-white amorphous powder
Grade: Injectable pharmaceutical excipient
Standards: EP / USP
CAS No.: 182410-00-0
Solubility in water: ≥ 100 g/100 mL (25°C)
Endotoxin: Controlled for parenteral use
Impurities: Strictly controlled
Degree of substitution: Consistent batch-to-batch
Shelf life: 36 months under recommended storage conditions

A Certificate of Analysis (COA) is provided with each batch.

Manufacturing & Supply Capability

Xi’an Deli Biochemical Industry Co., Ltd. is an established manufacturer of injectable-grade SBECD with reliable commercial-scale supply capabilities.

Annual production capacity: over 200 metric tons
Typical batch size: approximately 2.5 metric tons
Controlled clean manufacturing environment
ISO 9001 certified quality management system
Comprehensive analytical control of endotoxins, impurities, and substitution degree

Quality Assurance

Compliance with EP and USP requirements
Strict endotoxin and impurity control
Excellent batch-to-batch consistency
Full traceability and technical documentation
COA and technical data available upon request

Storage & Handling

Store in a cool, dry place in tightly sealed containers
Protect from moisture
Non-hazardous for transport under normal conditions

Why Choose Xi’an Deli Biochemical

Over 26 years of experience in cyclodextrin manufacturing
Dedicated production lines for injectable pharmaceutical excipients
Proven long-term supply to global pharmaceutical customers
Strong technical support for formulation development
Reliable quality and scalable production capacity

Contact Us

For samples, technical data, or quotations for Sulfobutylether Beta Cyclodextrin Sodium Salt (CAS 182410-00-0), please contact Xi’an Deli Biochemical Industry Co., Ltd.

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