Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients

Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients is a high-purity, anionic cyclodextrin derivative designed for pharmaceutical formulations requiring enhanced solubility and stability. Betadex Sulfobutyl Ether Sodium is a sodium salt obtained by sulfoalkylation of beta cyclodextrin under controlled alkaline conditions, resulting in excellent water solubility and strong inclusion complex capability.

Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients is widely used as a solubilizer, stabilizer, wetting agent, and complexing agent for poorly water-soluble active pharmaceutical ingredients. The anionic structure of Betadex Sulfobutyl Ether Sodium improves drug compatibility, reduces irritation, and supports safer parenteral administration.

In pharmaceutical applications, Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients helps enhance drug bioavailability, reduce renal toxicity, minimize hemolysis, mask unpleasant odors, and achieve controlled drug release. Betadex Sulfobutyl Ether Sodium is suitable for injectable, oral, nasal, and ophthalmic drug delivery systems.

Product Specifications

Product Name: Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients
CAS No.: 182410-00-0
Molecular Formula: C42H70-nO35·(C4H8SO3Na)n
Grade: Pharmaceutical Grade (USP / EP)
Assay: ≥ 99.0%
Appearance: White to off-white amorphous powder
Solubility: Freely soluble in water
Applications: Injectable and parenteral drug formulations
Packaging: 500 g/bag; 10 kg/drum; customized packaging available

Certificate of Analysis (COA)

Each batch of Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients is supplied with a complete Certificate of Analysis. The COA includes assay results, identification, impurities, residual solvents, heavy metals, bacterial endotoxin, and microbiological limits to ensure consistent pharmaceutical quality.

Company Introduction

Xi’an Deli Biochemical Industry Co., Ltd. is a professional manufacturer specializing in cyclodextrin derivatives since 1999. Xi’an Deli Biochemical focuses on the research, development, and production of pharmaceutical excipients, including Betadex Sulfobutyl Ether Sodium and Hydroxypropyl Betadex.

With over 20 years of manufacturing experience, Xi’an Deli Biochemical operates dedicated pharmaceutical production lines and controlled clean areas. Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients is produced under strict quality management systems, with stable batch consistency and long-term supply capability.

The company has passed ISO 9001:2015 certification, and products are supplied to global pharmaceutical customers for formulation development, clinical research, and commercial manufacturing.

FAQ

1. Is Xi’an Deli Biochemical the manufacturer of Betadex Sulfobutyl Ether Sodium?
Yes. Xi’an Deli Biochemical Industry Co., Ltd. is a direct manufacturer of Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients, with in-house production facilities and quality control.

2. Does Betadex Sulfobutyl Ether Sodium meet pharmacopeial standards?
Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients complies with USP and EP pharmaceutical excipient requirements.

3. Is a Certificate of Analysis provided?
Yes. A complete COA is provided with every shipment of Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients.

4. Are samples available for evaluation?

Yes. Samples of Betadex Sulfobutyl Ether Sodium Powder Pharmaceutical Excipients are available for formulation evaluation upon request.

5. What is the production capacity?
Xi’an Deli Biochemical operates stable commercial-scale production. Single batch capacity reaches 2.5 metric tons, with an annual output exceeding 200 metric tons to support long-term supply.

6. What documents are available for regulatory support?
COA, MSDS, technical specifications, and stability-related documentation can be provided to support pharmaceutical development and registration.