Betadex Sulfobutyl Ether Sodium Injectable Pharmaceutical Excipient

Betadex Sulfobutyl Ether Sodium Injectable Pharmaceutical Excipient EP & USP Grade (SBECD) is a high-purity, water-soluble cyclodextrin derivative developed for injectable and parenteral pharmaceutical formulations. This excipient improves solubility, stability, and bioavailability of poorly soluble active pharmaceutical ingredients (APIs) by forming stable, non-covalent inclusion complexes.

Betadex Sulfobutyl Ether Sodium Injectable Pharmaceutical Excipient EP & USP Grade is suitable for intravenous, intramuscular, and subcutaneous injections. It prevents precipitation, reduces chemical degradation, minimizes hemolysis, lowers renal toxicity, and supports sensitive APIs in injectable formulations. Its excellent safety profile and biocompatibility make it a preferred excipient for clinical and commercial injectable drugs.

Company Introduction

Xi’an DELI Biochemical Industry Co., Ltd. was established in 1999 and has over 26 years of experience in the research, production, and commercialization of cyclodextrin derivatives. Core products include Betadex Sulfobutyl Ether Sodium (SBECD) and Hydroxypropyl Betadex (HPBCD). DELI provides consistent high-purity products, strict quality control, technical support, and reliable global supply for pharmaceutical, veterinary, and cosmetic markets.

Betadex Sulfobutyl Ether Sodium Injectable Pharmaceutical Excipient EP & USP Grade - Product Specifications

CAS No: 182410-00-0
Molecular Formula: C42H70-nO35·(C4H8SO3Na)n
Grade: Injectable, EP and USP compliant
Appearance: White to off-white amorphous powder
Assay: ≥99.0%
Applications: Injectable and parenteral pharmaceutical formulations
Packaging: 500g/bag; 1kg/bag; 10kg/bag; 10kg/drum; customized packaging available
Storage: Sealed and dry
Shelf Life: 36 months
COA / Quality Assurance: Each batch is tested for assay, bacterial endotoxin, residual solvents, heavy metals, and average degree of substitution (DS) in accordance with EP and USP standards. Stability data, MSDS, and technical dossiers are available.

Product Applications

Betadex Sulfobutyl Ether Sodium is exclusively used for injectable and parenteral formulations. It enhances solubility, reduces hemolysis, lowers renal toxicity, and supports stable drug delivery in intravenous and intramuscular injections. SBECD forms inclusion complexes with nitrogen-containing APIs, improving stability and providing sustained release.

Marketed Injectable Products Using SBECD

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

COA / Quality Assurance

Each batch of Betadex Sulfobutyl Ether Sodium is supplied with a Certificate of Analysis (COA). Quality testing covers assay, identification, appearance, degree of substitution, residual solvents, heavy metals, bacterial endotoxin, and other critical quality attributes in accordance with EP and USP requirements. Stability data, MSDS, and technical documentation are available upon request.

FAQ

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

Q: Are samples available?
A: Yes, SBECD 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 is available by air, sea, or express courier.

Inquiry & Technical Support

Contact Xi'an DELI Biochemical to request samples, technical documentation, or quotations for Betadex Sulfobutyl Ether Sodium Injectable Pharmaceutical Excipient. Our technical team is ready to support your injectable formulation development with reliable supply and professional expertise.