Sulfobutylether Beta Cyclodextrin Sodium Powder

What is Sulfobutylether Beta Cyclodextrin Sodium Powder?

Sulfobutylether Beta Cyclodextrin Sodium Powder is a highly water-soluble, anionic β-cyclodextrin derivative used as a pharmaceutical excipient. It is produced by chemically modifying beta cyclodextrin with sulfobutyl ether groups under controlled alkaline conditions, resulting in a sodium salt with excellent solubilizing properties.

This injectable-grade excipient is designed to form stable, non-covalent inclusion complexes with poorly soluble active pharmaceutical ingredients (APIs). By encapsulating drug molecules, Sulfobutylether Beta Cyclodextrin Sodium Powder significantly improves drug solubility, stability, and bioavailability while reducing local irritation, hemolysis, and renal toxicity.

Due to its high safety profile and strong complexation ability, Sulfobutylether Beta Cyclodextrin Sodium Powder is widely used in parenteral pharmaceutical formulations, particularly for antifungal, antiviral, oncology, and cardiovascular injectable drugs. It complies with major pharmacopeial standards such as USP and EP and is suitable for clinical and commercial pharmaceutical applications.

Sulfobutylether Beta Cyclodextrin Sodium Powder Specification

Sulfobutylether Beta Cyclodextrin Sodium Powder COA

What is the use and benefits of Sulfobutyl Ether Beta Cyclodextrin (SBECD)?

1. Uses of Sulfobutyl Ether Beta Cyclodextrin (SBECD)

Sulfobutyl Ether Beta Cyclodextrin (SBECD) is mainly used as a pharmaceutical excipient, especially in:

• Injectable (parenteral) drug formulations
• Ophthalmic (eye) preparations
• Nasal and pulmonary drug delivery systems
• Formulations of poorly water-soluble APIs, such as antifungal, antiviral, anticancer, and cardiovascular drugs

2. Benefits of Sulfobutyl Ether Beta Cyclodextrin (SBECD)

• Significantly improves water solubility of poorly soluble drugs
• Enhances drug stability by forming non-covalent inclusion complexes
• Improves drug safety, especially for injectable formulations
• Reduces renal toxicity compared with some traditional solubilizers
• Minimizes hemolysis and injection site irritation
• Controls drug release rate, improving therapeutic performance
• Masks unpleasant odor or taste of APIs
• High aqueous solubility and low toxicity, suitable for parenteral use

Why Choose Us?

Over 20 Years of Manufacturing Experience

With more than two decades of dedicated experience in cyclodextrin and cyclodextrin derivative manufacturing, Xi’an Deli Biochemical Industry Co., Ltd. has built a solid reputation for product quality, process stability, and reliable supply.

Large-Scale and Stable Production Capacity

We operate industrial-scale production lines with an annual capacity of 500 tons of Hydroxypropyl Betadex and 200 tons of Betadex Sulfobutyl Ether Sodium, ensuring stable supply for long-term commercial and clinical applications.

Pharmaceutical-Grade Quality Assurance

Our products are manufactured under a strict quality management system, with a dedicated Class D clean area designed according to pharmaceutical production requirements. Comprehensive in-process and final product testing ensures excellent batch-to-batch consistency.

Advanced Analytical and Testing Capabilities

Equipped with modern analytical instruments such as HPLC, GC, IC, capillary electrophoresis, FTIR, and NMR-supported testing, our laboratory is capable of meeting pharmacopeial requirements of USP, EP, and ChP, supporting formulation development and regulatory compliance.

Regulatory Support and Global Market Experience

Our key products, including Hydroxypropyl Betadex and Betadex Sulfobutyl Ether Sodium, have been registered and filed with the FDA, demonstrating our experience in supporting customers for global pharmaceutical markets.

Customer-Oriented Technical Support

We provide professional technical support, documentation assistance, and formulation-related guidance, working closely with customers from early development through long-term commercial supply.

Qualification of Company

Xi’an Deli Biochemical Industry Co., Ltd. Certificates.

Over the years, Xi’an Deli Biochemical Industry Co., Ltd. has been continuously committed to manufacturing process optimization and the establishment of a comprehensive quality management system for cyclodextrins and their derivatives.

FAQ

1. Are you a manufacturer or a trading company?

We are a professional manufacturer specializing in cyclodextrin and cyclodextrin derivatives. All products are produced at our own manufacturing facility in Xi’an, China.

2. What are your main products?

Our main products are Hydroxypropyl Betadex (HPBCD) and Betadex Sulfobutyl Ether Sodium (SBECD), which are widely used as pharmaceutical excipients, especially in injectable and oral formulations.

3. Do your products meet pharmacopeial standards?

Yes. Our products comply with USP, EP, and Chinese Pharmacopoeia requirements. Full Certificates of Analysis (COA) are provided with each batch.

4. Do you supply injectable-grade materials?

Yes. We specialize in injectable-grade cyclodextrin derivatives with strict control of impurities, endotoxins, and batch-to-batch consistency.

5. What is your production capacity?

Hydroxypropyl Betadex: 500 metric tons per year

Betadex Sulfobutyl Ether Sodium: 200 metric tons per year

6. Do you provide samples for evaluation?

Yes. Free samples are available upon request for formulation development and testing.

7. Can you support long-term commercial supply?

Yes. With large-scale production lines and stable quality systems, we support long-term and commercial-scale supply for global pharmaceutical customers.

8. What quality systems do you follow?

We operate under ISO 9001:2015, supported by advanced analytical equipment and a dedicated quality control laboratory to ensure product consistency and compliance.