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Betadex sulfobutyl ether sodium

Normally its elimination from the kidneys is rapid and complete after administration. In vitro experiments and in vivo acute, subacute and chronic toxicity studies provide safe data and approved for use in human pharmaceutical preparations.

Subcategory:

Pharmaceutical Cyclodextrin

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Product Information:

Product Name:BETADEX SULFOBUTYL ETHER SODIUM

Quality standard: USP-NF2023, EP10.3, enterprise standard

Appearance: white powder

CAS NO.：182410-00-0

Molecular formula:C₄₂H₇0-nO₃₅(C₄H₈SO₃Na)n , n is the degree of substitution

Molecular weight:1134+158n

Product features and applications

Betadex Sulfobutyl Ether Sodium, also known as sulfobutyl ether betacyclodextrin sodium salt, is the sodium salt of betacyclodextrin alkylated by 1,4-butanesulfonolactone under alkaline conditions, is an anionic, highly water-soluble cyclodextrin derivatives, which can be very well encapsulated with the drug molecules to form a non-covalent complex, thus improving the stability of the drug, water solubility, safety, reducing nephrotoxicity, moderating the hemolysis of the drug, controlling the release of the drug rate, masking bad odor, etc.

Route of administration】：Injection, oral, nasal, ophthalmic, with special affinity and encapsulation for nitrogen-containing drugs.

Product Performance:

1. Solubilization:

Neutral, positive and negative APIs can be effectively combined with sulfobutyl betacyclodextrin, so that the solubility of compounds with different solubility in API water can be increased by 10 to 25,000 times.

2. Convenient drug delivery:

Sulfobutylbeta cyclodextrin has good biocompatibility and can be administered by injection, oral, ocular, nasal, topical and inhalation.

3. Good safety:

4. Good Stability:

Interaction with sulfobutyl betacyclodextrin can provide a beneficial protective environment for the API in its lipophilic cavity, while the hydrophilic surface provides excellent water solubility providing solubility and stability.

Testing Standards:

Test items		Statutory standard（USP-NF2023）
Appearance		White or off-white amorphous powder
Solubility		It is soluble in water, slightly soluble in methanol, almost insoluble in ethanol, hexane, n-butane, acetonitrile, isopropanol and ethyl acetate.
Appraise	Infrared Spectroscopy	Same absorption band as the standard
	Liquid phase (chemistry)	The retention time of the main peak of the sample solution should be the same as that of the standard solution.
	Average substitution	should comply with regulations
	Na	Sodium salt reaction
Content		95.0%-105.0%
Aqueous solution pH		30% w/v aqueous solution pH 4.0-6.8
Heavy metal		≤5ppm
Betacyclodextrin		≤0.1%
1,4-Butanesulfonolactone		≤0.5ppm
NaCl		≤0.2%
4-Hydroxybutane-1-sulfonic acid		≤0.09%
Disodium bis(4-sulfobutyl) ether		≤0.05%
Bacterial endotoxin		≤10Eu/g
Total aerobic bacteria		≤100cfu/g
Total Molds and Yeasts		≤50cfu/g
Escherichia coli (E. coli)		Not detectable
Solution Clarity		The 30% (W/V) solution was clarified.
Average substitution		6.2-6.9
Peak (% peak area)	I	0.0-0.3
	II	0.0-0.9
	III	0.5-5.0
	IV	1.0-10.0
	V	10.0-20.0
	VI	15.0-25.0
	VII	20.0-30.0
	VIII	10.0-25.0
	IX	2.0-12.0
	X	0.0-4.0
PH (chemistry)		4.0-6.8
Moisture content		≤10.0%
Storage conditions		Keep sealed, protected from moisture and at room temperature