Sulfobutyl Ether Beta Cyclodextrin Pharmaceutical Excipient

Sulfobutyl Ether Beta Cyclodextrin Pharmaceutical Excipient

CAS: 182410-00-0
Appearance: White powder, sweet, insipid and innocuous
Grade: Injectable grade
Application: Pharmaceutical field
Standard: USP, EP
Solubility: ≥100 g/100ml (25℃)
Heavy metal: ≤0.0025%
Reducing sugars: ≤0.05%
Shelf life: 36 months

Product Description

Sulfobutyl Ether Beta Cyclodextrin Pharmaceutical Excipient is a high-purity, highly water-soluble anionic β-cyclodextrin derivative specifically designed for injectable pharmaceutical formulations. SBEβCD enhances drug solubility, improves stability and safety, reduces stimulation at the injection site, and ensures rapid attainment of therapeutic blood concentrations while prolonging drug action.

SBEβCD is a sodium salt produced when Betadex is alkylated by 1,4-butanesulfonic acid lactone under alkaline conditions. This anionic, water-soluble derivative forms non-covalent complexes with drug molecules, improving stability, solubility, and safety. It reduces renal toxicity, minimizes hemolysis, controls drug release, and can mask unpleasant odors.

Company Introduction

Xi'an DELI Biochemical Industry Co., Ltd. was established in 1999 and has over 26 years of experience producing cyclodextrin derivatives, including Sulfobutyl Ether Beta Cyclodextrin (SBECD) and Hydroxypropyl Betadex (HPBCD). The company operates advanced production lines and strict quality control systems to ensure high-purity, consistent products for global pharmaceutical markets.

Product Applications

Sulfobutyl Ether Beta Cyclodextrin is exclusively used for injectable formulations. It enhances solubility and stability of poorly soluble APIs, reduces renal toxicity, minimizes hemolysis, and improves patient compliance. SBEβCD is suitable for intravenous, intramuscular, and subcutaneous injections, and forms stable inclusion complexes with nitrogen-containing APIs.

Already marketed products using SBECD include Remdesivir, Mephalan Hydrochloride Injection, Posaconazole Injection, Cerlaprazole Mesylate, and Voriconazole Injection.

COA / Quality Assurance

Each batch of SBEβCD is tested for assay purity, heavy metals, reducing sugars, bacterial endotoxins, and residual solvents, meeting USP and EP pharmacopeial standards. Average Degree of Substitution (DS) and other parameters are strictly controlled to ensure safety, consistency, and regulatory compliance.

FAQ

Q: Is Xi'an DELI Biochemical the manufacturer of SBECD?
A: Yes, Xi'an DELI Biochemical produces Sulfobutyl Ether Beta Cyclodextrin and Hydroxypropyl Betadex. Beta-Cyclodextrin is used as the raw material.

Q: Are samples available?
A: Yes, samples are available for evaluation.

Q: What is the batch and annual production capacity?
A: SBECD batch production capacity is 2.5 tons, and annual output exceeds 200 tons.

Q: What regulatory documents are provided?
A: COA, MSDS, stability data, and technical dossiers are available for all batches.

Q: Shipping options?
A: Global shipping by air, sea, or express courier.

Inquiry & Technical Support

Contact Xi'an DELI Biochemical to request samples, technical documentation, or quotations for Sulfobutyl Ether Beta Cyclodextrin (SBEβCD). Our technical team provides professional support for injectable formulation development.