SBECD Sulfobutyl Cyclodextrin Sodium 182410-00-0

SBECD Sulfobutyl Cyclodextrin Sodium, also known as Sulfobutyl Ether Beta Cyclodextrin Sodium, is a highly water-soluble, anionic cyclodextrin derivative widely used as an injectable pharmaceutical excipient. With CAS No. 182410-00-0, this product is specifically developed to improve the solubility, stability, and safety of poorly water-soluble active pharmaceutical ingredients (APIs).

By forming stable, non-covalent inclusion complexes with hydrophobic drug molecules, SBECD enables effective parenteral formulation of APIs that are otherwise difficult to dissolve in aqueous systems. Its favorable safety profile and excellent biocompatibility make it suitable for repeated intravenous administration.

Product Overview

SBECD Sulfobutyl Cyclodextrin Sodium is manufactured through controlled chemical substitution of beta cyclodextrin with sulfobutyl ether groups, followed by conversion to the sodium salt form. This structural modification significantly enhances aqueous solubility while maintaining strong inclusion capability for lipophilic APIs.

The unique molecular structure consists of a hydrophobic internal cavity and a hydrophilic outer surface, allowing drug molecules to be encapsulated efficiently and dispersed uniformly in water-based formulations. This results in improved drug bioavailability and formulation stability without the use of aggressive solubilizers.

Pharmaceutical Applications

SBECD Sulfobutyl Cyclodextrin Sodium is primarily applied in injectable and parenteral drug products. It is widely used in formulations for antifungal, antiviral, oncology, and cardiovascular therapies, particularly for APIs with low aqueous solubility and high potency.

The product has a proven track record in commercial injectable medicines, supporting critical care and hospital-use drugs where formulation safety, consistency, and regulatory acceptance are essential.

Product Specifications

Product Name: SBECD Sulfobutyl Cyclodextrin Sodium
CAS No.: 182410-00-0
Appearance: White to off-white, amorphous powder
Grade: Injectable pharmaceutical excipient
Pharmacopoeial Standards: USP / EP / ChP
Assay: 95.0% – 105.0% (anhydrous basis)
Bacterial Endotoxins: ≤ 10 EU/g
Degree of Substitution: Strictly controlled for batch consistency

SBECD Sulfobutyl Cyclodextrin Sodium 182410-00-0 COA

Manufacturing Strength & Company Introduction

Xi’an Deli Biochemical Industry Co., Ltd. is a professional manufacturer specializing in cyclodextrins and cyclodextrin derivatives. Founded in 1999, the company has more than 25 years of experience in pharmaceutical excipient research, process development, and large-scale manufacturing.

Deli Biochemical focuses on two core products: Hydroxypropyl Betadex (HPBCD) and Sulfobutyl Cyclodextrin Sodium (SBECD). Through continuous process optimization and strict quality control, our products are supplied to pharmaceutical customers worldwide for both clinical development and commercial production.

Our manufacturing facilities are designed to meet pharmaceutical production requirements, including controlled clean areas and validated production processes. With an annual production capacity of approximately 200 metric tons of SBECD, we are able to ensure stable and reliable long-term supply.

Quality Assurance

Quality assurance is integrated into every stage of production. Each batch of SBECD Sulfobutyl Cyclodextrin Sodium undergoes comprehensive testing, including identification, purity, impurity profiling, endotoxin testing, and degree of substitution analysis.

Our quality management system is certified to ISO 9001 standards and supported by advanced analytical equipment such as HPLC, ion chromatography, gas chromatography, and capillary electrophoresis. Complete Certificates of Analysis are provided with every batch.

Our Advantages & Product Differentiation

Unlike general chemical suppliers, Xi’an Deli Biochemical Industry Co., Ltd. has focused exclusively on cyclodextrins and their derivatives for more than 25 years. This long-term specialization allows us to continuously optimize synthesis routes, purification processes, and quality control strategies specifically for pharmaceutical-grade cyclodextrin excipients.

SBECD Sulfobutyl Cyclodextrin Sodium produced by Deli Biochemical is manufactured using a proprietary, well-controlled process that ensures stable substitution distribution, low residual impurities, and excellent batch-to-batch consistency. Compared with conventional suppliers, our product demonstrates superior reproducibility in critical quality attributes such as degree of substitution, endotoxin level, and inclusion performance.

One key advantage of our SBECD is its reliable performance in injectable formulations. Through strict control of raw materials, reaction conditions, and purification steps, we effectively minimize residual beta cyclodextrin, organic impurities, and by-products, helping customers reduce formulation risks and simplify regulatory submissions.

From a supply perspective, Deli Biochemical operates dedicated large-scale production lines for SBECD with an annual capacity of approximately 200 metric tons. This enables us to support long-term commercial supply, multi-batch clinical programs, and demand scale-up without changes in manufacturing route or product specifications.

In addition to product quality, we provide strong technical support throughout the customer lifecycle. Our team offers documentation packages, analytical data, and formulation-related guidance to assist customers during development, technology transfer, and commercialization stages.

As a direct manufacturer with in-house production and testing capabilities, Xi’an Deli Biochemical delivers not only competitive supply security but also transparent communication, shorter response times, and long-term partnership value for global pharmaceutical companies.

Contact Us

For samples, technical documents, or commercial inquiries regarding SBECD Sulfobutyl Cyclodextrin Sodium 182410-00-0, please contact Xi’an Deli Biochemical Industry Co., Ltd. We look forward to supporting your formulation development and long-term supply needs.

FAQ

Q: Is SBECD Sulfobutyl Cyclodextrin Sodium suitable for injectable formulations?

A: Yes. This product is specifically manufactured as an injectable-grade pharmaceutical excipient and complies with major pharmacopoeial standards such as USP and EP.

Q: What types of APIs can be formulated with SBECD?

A:SBECD is particularly effective for poorly water-soluble APIs, including antifungal, antiviral, oncology, and cardiovascular drugs, where enhanced solubility and stability are required.

Q: Can SBECD be used in both clinical and commercial manufacturing?

A: Yes. Our SBECD is supplied for both clinical development and commercial-scale production, with consistent quality and batch-to-batch reproducibility.

Q: Do you provide technical documentation and samples?

A: Yes. Technical data, Certificates of Analysis, and samples can be provided upon request to support formulation development and evaluation.