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Sulfobutyl ether beta cyclodextrin sodium CAS 182410-00-0 Injection grade
Time：2021/08/10


Sulfobutyl ether beta cyclodextrin sodium CAS 182410-00-0 Injection grade 

Product Introduction

Sulfobutyl ether beta cyclodextrin sodium 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.

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Quick Details

Product NameSulfobutyl ether beta cyclodextrin sodium
CAS No.182410-00-0
Other NamesSBECD
Molecular Formula  C42H70-nO35 (C4H8O3S Na)n
Molecular Weight  1135+158n
TypeAuxiliaries and Other Medicinal Chemicals
Grade StandardMedicine Grade
UsageAnimal Pharmaceuticals
Brand NameBinzhou
Purity95%min
Shelf life36 months
GradeInjection
StandardUSP, EP, In-house Standard
ApplicationPharmaceuticals
Solubility≥100(25℃,g/100ml)
Samplefree of charge
Place of OriginShandong, China (Mainland)

 

Product Specification

Standard USP
ITEMSSPECIFICATION
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 pHpH of 30%w/v solution in water is 4.0-6.8
Water content≤10.0%
β-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%
Assay95.0%-105.0%
Bacterial endotoxins≤20EU/g
                                       Microbiology
TAMC ( cfu/g)≤100 cfu/g
TYMC ( cfu/g)≤50 cfu/g
Escherichia ColiAbsence

Application of SBECD


Sulfobutyl ether beta cyclodextrin sodium is a new type of anionic high soluble cyclodextrin derivatives, which can be used as a solubilizer, wetting agent, chelating agent (complexing agent) and polyvatent masking agent. 

It has been used in injection, oral, nasal and eye medicines. It has a special affinity and inclusion for nitrogen drugs. 

  • Increase the drug's stability ,solubility ,safety (Include drug molecules to form non-covalent) 

  • Reduce renal toxicity, ease drug hemolysis

  • Control the drug release rate, cover the bad smell 





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Packaging & Delivery

Packaging Details: 10kg/drum,20kg/drum

Port: Qingdao,Beijing,Shanghai,Tianjin

Lead Time: The expected delivery time is within 1-2 days after receive payment.


Delivery $ Payment

Payment          : T/T in advance, LC at sigh,DP

Delivery           : Can delivery goods within 1-2 days after receipt the payment.


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



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