Sulfobutylether-Beta-Cyclodextrin Sodium Salt

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Sulfobutylether-Beta-Cyclodextrin Sodium Salt

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Sulfobutylether-Beta-Cyclodextrin Sodium Salt

Abbreviation SBECD

Catalog CD182410000

CAS Number 182410-00-0

Cyclodextrin Type Anionic cyclodextrins

Packaging 20 kg

Storage Condition Store at room temperature, in tightly closed container

Availability In stock

*On-demand pack size is available, please contact us for multi-kilograms pack sizes.

Product Description

Sulfobutylether-beta-cyclodextrin sodium salt, also abbreviated as SBECD, is an anionic CD derived from glucose. Its molecular structure is shaped like a tapered cylinder with a cavity that can include other guest molecules. SBECD is a β-CD derivative obtained by replacing native β-CD with sulfobutyl ether groups and sodium ions along the length of the molecule. Considering the cost, cavity size, and toxic effects of native CDs, SBECD with superior solubility properties was developed. As a commonly used pharmaceutical CD, SBECD is primarily used to enhance the solubility of poorly soluble drugs as an excipient or formulation ^[1].

Basic Information

Average Molecular Formula	C₄₂H_70-nO₃₅·(C₄H₈O_3SNa)_n
Average Molecular Weight	1135.0 + n·(158.2)
Average Degree of Substitution [DS]	6.2-6.9
Possible Impurities	4-Hydroxybutane-1-sulfonic acid sodium salt, bis(4-sulfobutyl) ether disodium, residual beta-cyclodextrin
Solubility (in 100 cm³ solvent, at 25 °C)	Water: > 50 g Methanol: < 0.5 g Acetone: < 0.5 g

Detailed Information

Physical & Chemical Properties

Appearance	White or off-white powder
Content	95.0% - 105.0%
Appearance of aqueous solution (30%, w/v)	The solution is clear.
pH (30%, w/v)	4.0-6.8
Loss on drying	Max. 10.0%

Peak Distribution

*Each SBECD peak (I-X) meets the limit range (peak area %) of the Monograph

SBECD sodium peaks	I (DS-1)	II (DS-2)	III (DS-3)	IV (DS-4)	V (DS-5)	VI (DS-6)	VII (DS-7)	VIII (DS-8)	IX (DS-9)	X (DS-10)
Limit range(% peak area)	0-0.3	0-0.9	0.5-5.0	2.0-10.0	10.0-20.0	15.0-25.0	20.0-30.0	10.0-25.0	2.0-12.0	0-4.0

Identification

Identification: IR	Conforms with SBECD reference
Identification: HPLC	t_R of major peak conforms with SBECD reference
Identification: Average degree of substitution	Meet requirements
Identification: Sodium test	Positive test for sodium

Impurities

Residual beta-cyclodextrin (β-CD)	Max. 0.1%
Residual 1,4-butane sultone	Max. 0.5 ppm
Residual sodium chloride	Max. 0.2%
Residual 4-Hydroxybutane-1-sulfonic Acid	Max. 0.09%
Residual Bis(4-sulfobutyl) Ether Disodium	Max. 0.05%
Heavy metals	Max. 5 ppm

Microorganism

Total aerobic microbial count (TAMC)	Max. 100 cfu/g
Total yeast and mold count (TYMC)	Max. 50 cfu/g
Escherichia coli	Not detectable

Applications

SBECD has excellent solubility and is mainly used for the solubilization of drugs. Some drugs with a lipophilic or high molecular weight have poor water solubility and low bioavailability, which limits their application ^[1]. As an excipient, SBECD improves the solubility of drugs, offering an option for developing effective drug candidates. Currently, SBECD is used in a drug called Voriconazole.

Sulfobutylether-Beta-Cyclodextrin Sodium Salt

Voriconazole is a medication used to treat serious fungal or yeast infections and is available as tablets and a parenteral solution. The former is an oral formulation, while the latter uses SEBCD as a solubilizer. Notably, a voriconazole solution in SBECD for intravenous administration is already marketed. By loading-dose administration of a SEBCD-based parenteral solution intravenously, steady-state plasma concentrations can be achieved faster than with oral tablets ^[2,3].

Related Products

As one of the leading CD companies, Alfa Chemistry has a dedicated team which has accumulated extensive expertise in the field of CD chemistry. We offer high quality SBECDs in multi-kilogram quantities tailored to the special needs of the pharmaceutical and other industries. We do our best to provide customers with first-class products and services. For more information, please feel free to contact us.

References

Acharya, P. C.; et al. Solubility and solubilization approaches in pharmaceutical product development. Dosage Form Design Considerations. 2018, 513–547.
Shoham, S.; et al. Systemic antifungal agents. Infectious Diseases (Fourth Edition). 2017,2: 1333-1344.
Rex, J. H.; Stevens, D. A. Drugs active against fungi, Pneumocystis, and Microsporidia. 2015(1): 479-494.

It should be noted that our our products and services are for research use only, not for clinical use.

Product Description

Basic Information

Detailed Information

Applications

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