Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

Product Detail

Injection grade Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

1.Product Introduction of the Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

This Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.









2.Basic information of the Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

Product Name      : Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

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CAS NO.           : 182410-00-0

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Synonyms            : BETADEX SULFOBUTYL ETHER SODIUM

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Molecular Formula   : C₄₂H_70-nO₃₅ (C₄H₈O₃S Na)n

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Molecular Weight    : 1135+158n

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3.Product Specification of Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

Standard	USP40-NF35
ITEMS	SPECIFICATION
Clarity of Solution	A 30%w/v solution in water is clear and essentially free from particles of foreign matter
Identification (IR)	Same absorption bands as USP betadex sulfobutyl ether sodium RS
Identification(Sodium)	Identify test are positive for Sodium
Identification(LC)	the retention time of the major peak of  sample solution corresponds to the  standard solution
Average Degree of Substitution	6.2-6.9
Water solution pH	pH of 30%w/v solution in water is 4.0-6.8
Heavy Metals	=5ppm
Water content	=10.0%
ß-Cyclodextrin Content	=0.1%
Sodium Chloride	=0.2%
1,4-butane sultone	=0.5ppm
4-Hydroxybutane-1-Sulfonic Acid	=0.09%
Disodium bis-(4-sulfobtyl) ether	=0.05%
Assay	95.0%-105.0%
Bacterial endotoxins	=20EU/g
Microbiology
TAMC ( cfu/g)	=100 cfu/g
TYMC ( cfu/g)	=50 cfu/g
Escherichia Coli	Absence




4. Application of SBECD

?  Improve the stability of the drug, water solubility, safety

?  Reduce renal toxicity, ease drug hemolysis

?  Control the drug release rate, cover the bad smell



5.Packing & Shipping

Packing Detail       : 500g/bag, 1kg/bag, 2kg/bag, 10kg/drum, 20kg/drum or customized

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Shipping            : by Express,such as Fedex,DHL,EMS,TNT (Express can supply door to door service.Easy to pick up the goods.usually 3-5 days can arrived your address

                       Shipped by air or by sea

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6.Delivery $ Payment

 Payment          : Arrange payment to our Paypal account:zhiyuansw@163.com

Or T/T in advance by our our remittance route for US dollors

Delivery          : Can delivery goods immediately after receipt the payment.

Availability      :  In stock

Port of loading   : factory of Zhiyuan(China)




7.FAQ

? Is there an established, documented Quality System that is maintained to ensure products conform to requirements?

? Yes




? Is the excipient manufactured as a continuous or a batched process?

? Batched process




? Are there complete written manufacturing instructions, as controlled GMP documents?

? Yes




? Is the manufacturing process validated?

? Yes




? Do you use any Class I, Class II, or Class III solvents specified in the USP during the manufacturing of the excipient(s)?

? No