ProductName: sulfobutyl ether β-cyclodextrin (SBE7-β-CD)
Quality Standard: USP & the Company quality standard of Sulfobutyl Ether-β-Cyclodextrin Sodium Salt (2007)
IUPAC Name: 4-Methoxy-6-sulfanilamidopyrimidine sodium salt
Molecular Formula: (C6H10-nO5 )7(C4H8SO3Na+)n
Molecular weight: average 2163 (based on average degree of substitution of 6.5)
Use: SBE7-β-CD is a sulfobutyl ether derivative of β-cyclodextrin with an average of seven sulfobutyl ether groups per cyclodextrin molecule. Because of the very low pKa of the sulfonic acid groups, SBE7-β-CD carries multiple negative charges at physiologically compatible pH values. The four-carbon butyl chain coupled with repulsion of the end group negative charges allows for an "extension" of the cyclodextrin cavity. This often results in stronger binding to drug candidates than seen with other modified cyclodextrins. In addition, these derivatives impart exceptional solubility and parenteral safety to the molecule. In general, SBE7-β-CD will complex with many hydrophobic compounds that have structural features that can fit within the cyclodextrin cavity. A significant amount of literature is available illustrating the types of compounds that are candidates for inclusion complexation, but confirmation must be made by conducting a few simple laboratory tests. SBE7-β-CD will complex with peptides and proteins, can be used in injectable formulations, can be given by non-parenteral routes and is suitable for use in solid formulations.
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Items
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Regular grade
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Injection grade(USP)
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Appearance
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White to light-yellow powder, colorless, odorless
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White to off-white essentially freely from foreign matter
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Solution clarity
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--
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30%w/v solution in water is clear and essentially free form particles of foreign matter
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Identification
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--
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IR
Sodium test
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Water solution PH
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--
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pH of 30%w/v solution in water is 4.0-6.8
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Heavy metals
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25ppm max
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5ppm max
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As
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2ppm max
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--
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Water
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4.5%max
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10% max
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Residue on ignition
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20%max
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--
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Average degree of substitution
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--
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6.2-6.9
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SBE I content
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--
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0.2%max
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SBE II content
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--
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0.8%max
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β-cyclodextrin content
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--
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0.1%max
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Sodium chloride
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--
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0.2% max
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1,4-Butane sultone
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--
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0.5ppm max
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4-Hydroxybutanol sulfonic acid
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--
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0.09%max
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Disodium bis(4-sulfobutyl)ether
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--
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0.05%max
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Assay
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98.0%min
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95.0-105.0%
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Total bacteria
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1000cfu/g max
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--
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Total Mould
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100cfu/g max
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--
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Pathogenic bacteria
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N.D
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--
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Bacterial Endotoxin
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--
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10EU/g max
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Aerobic microorganism
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--
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100cfu/g max
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Escherichia coli
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--
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Negative
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Salmonella
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--
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Negative
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Mould & yeasts
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--
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50cfu/g max
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>>Alphabetical order
