Sulfobutyl Ether Beta Cyclodextrin Sodium (SBECD) for Injection

Sulfobutyl Ether Beta Cyclodextrin Sodium (SBECD) for Injection is a highly purified anionic cyclodextrin derivative manufactured by Xi’an DELI Biochemical Industry Co., Ltd. It is developed as a pharmaceutical excipient for parenteral formulations where enhanced solubility, formulation stability, and patient safety are essential.

SBECD improves the aqueous solubility of poorly water-soluble active pharmaceutical ingredients through reversible, non-covalent inclusion complex formation. This interaction enables drug molecules to be temporarily encapsulated within the cyclodextrin cavity without chemical modification, preserving the original pharmacological activity of the API.

Thanks to its excellent water solubility and strong complexation capacity, SBECD is widely used in injectable formulations, particularly for lipophilic and nitrogen-containing drugs. In addition to parenteral use, it is suitable for oral liquid, nasal, and ophthalmic dosage forms.

Technical Advantages

1. High aqueous solubility suitable for injectable formulations
2. Efficient solubilization of poorly water-soluble and lipophilic APIs
3. Enhances formulation stability and reduces precipitation risk
4. Lower renal toxicity and reduced hemolytic potential compared with traditional solubilizers
5. Forms reversible non-covalent inclusion complexes without chemical modification
6. Controlled degree of substitution ensuring consistent performance
7. Injection grade quality compliant with USP requirements

Quality Control & Specifications

Each batch of Sulfobutyl Ether Beta Cyclodextrin Sodium (SBECD) for Injection is produced under a strict quality management system and released only after comprehensive quality testing in accordance with USP requirements.

Quality Assurance & Documentation

SBECD for Injection is manufactured under a robust quality management system to ensure consistent product quality, safety, and regulatory compliance.

Our company holds complete and valid corporate and manufacturing qualifications, including a Business License, Pharmaceutical Manufacturing License, HALAL certification, and other relevant regulatory approvals. A Drug Master File (DMF) has been established to support product registration and regulatory submissions in applicable markets.

Supporting technical documentation, quality agreements, and regulatory-related materials are available upon request to assist customers with formulation development, compliance evaluation, and product registration.

Manufacturer Profile

Xi’an DELI Biochemical Industry Co., Ltd. was established in 1999 and specializes in the research, development, and production of cyclodextrins and cyclodextrin derivatives. With more than two decades of industry experience, the company has built strong technical expertise in pharmaceutical excipients.

DELI Biochemical focuses on providing high-quality, compliant excipients for pharmaceutical, veterinary, and chemical applications. The company operates with stable production processes, well-defined quality systems, and strict control from raw material sourcing to finished product release.

Through continuous process optimization and consistent batch-to-batch control, Xi’an DELI Biochemical Industry Co., Ltd. supplies reliable products to customers worldwide and supports long-term cooperation with formulation developers and pharmaceutical manufacturers.

Frequently Asked Questions

1.What is Sulfobutyl Ether Beta Cyclodextrin Sodium (SBECD) for Injection mainly used for?

SBECD for Injection is primarily used as a pharmaceutical excipient to improve the aqueous solubility, stability, and formulation performance of poorly water-soluble active pharmaceutical ingredients, especially in parenteral formulations.

2.Is this product suitable for injectable formulations?

Yes. This product is manufactured as injection grade and complies with USP requirements for parenteral pharmaceutical use.

3.Does SBECD chemically modify the active pharmaceutical ingredient?

No. SBECD forms reversible, non-covalent inclusion complexes with drug molecules and does not chemically modify the API or alter its pharmacological activity.

4.What types of drugs are suitable for complexation with SBECD?

SBECD is particularly suitable for lipophilic and nitrogen-containing drugs with poor water solubility. It has been widely used to improve solubility and formulation stability of such compounds.

5.Can SBECD help reduce formulation-related toxicity?

Compared with some traditional solubilizers, SBECD demonstrates lower renal toxicity and reduced hemolytic potential, which contributes to improved formulation safety when used appropriately.

6.What dosage forms can use SBECD for Injection?

In addition to injectable formulations, SBECD can also be used in oral liquid, nasal, and ophthalmic dosage forms, depending on formulation requirements.

7.Is a Certificate of Analysis provided with each batch?

Yes. Each batch is supplied with a complete Certificate of Analysis (COA), covering identification, assay, impurity limits, bacterial endotoxins, microbial limits, and degree of substitution.

8.What is the shelf life of SBECD for Injection?

The shelf life is 36 months when stored in sealed containers under recommended storage conditions.

9.Is technical or regulatory support available?

Yes. Technical documentation and regulatory-related support materials can be provided upon request to assist formulation development and product registration.