Company Details

  • Zhiyuan Biotchnology

  •  [Shandong,China]
  • Business Type:Manufacturer
  • Main Mark: Africa , Americas , Asia , Caribbean , Europe , North Europe , Oceania , West Europe , Worldwide , East Europe , Middle East
  • Exporter:51% - 60%
  • Certs:ISO9001, ISO14001, FDA
  • Description:FDA Approved Sulfobutyl Ether Beta Cyclodextrin,DMF Approved Sulfobutyl Ether Beta Cyclodextrin,Medical Sulfobutyl Ether Beta Cyclodextrin Sodium
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Zhiyuan Biotchnology

FDA Approved Sulfobutyl Ether Beta Cyclodextrin,DMF Approved Sulfobutyl Ether Beta Cyclodextrin,Medical Sulfobutyl Ether Beta Cyclodextrin Sodium

Home > Products > Sulfobutyl/Methyl Beta Cyclodextrin > Sulfobutyl Beta Cyclodextrin > FDA DMF approved sulfobutyl ether beta cyclodextrin

FDA DMF approved sulfobutyl ether beta cyclodextrin

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    Payment Type: L/C,T/T,D/P,Paypal
    Incoterm: FOB,CFR,CIF
    Min. Order: 1 Kilogram
    Delivery Time: 1 Days

Basic Info

Model No.: ZY-004

Certification: FDA

Grade Standard: Medicine Grade

Type: Chemical Reagent

State: Solid

Volatile: Not Volatile

Additional Info

Packaging: 10kg/drum,20kg/1drum

Productivity: 5000kgs

Brand: Zhiyuan

Transportation: Ocean,Land,Air

Place of Origin: China

Supply Ability: 5000kgs

Certificate: FDA certified Halal and Certified

Product Description

DMF No.: 030167

Name: sulfobutyl ether-beta-cyclodextrin sodium salt

Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt

CAS: 182410-00-0

Abbreviation: SBEBCD

Molecular formula : C42H70-nO35 (C4H8O3S Na)n

Molecular weight: 1135+158n

Solubility(in 100cm3 solvent, at 25℃) : water: >50g

Methanol: <0.5g

Acetone : <0.5g

Qaulity : injection grade / oral grade

Standard : USP38 / EP8.0

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

Use : medical

Specification : USP38



ITEMS

SPECIFICATION

RESULTS

Appearance

White to off-white solid, free from foreign matter

Qualify

Solution Clarity

A 30%w/v solution in water is clear and essentially free from particles of foreign matter

Qualify

Identification (IR)

Consistent with SBECD standard

Qualify

Sodium Identification

Identify test are positive for Sodium

+

Average Degree of Substitution

6.2-6.9

6.7

SBE 1 Content

≤0.2%

0.05%

SBE 2 Content

≤0.8%

0.15%

Water solution pH

pH of 30%w/v solution in water is 4.0-6.8

5.4

Heavy Metals

≤5ppm

<5ppm

Water

≤10%

4.0%

β-Cyclodextrin Content

≤0.1%

Absence

Sodium Chloride

≤0.2%

0.01%

1,4-butane sultone

≤0.5ppm

0.3ppm

4-Hydroxybutane-1-Sulfonic Acid

≤0.09%

0.01%

Disodium bis-(4-sulfobtyl) ether

≤0.05%

0.05%

Assay

95%-105%

99.5%

Bacterial endotoxins

≤25EU/g

≤20EU/g

Microbiology

Total viable aerobic count (mould plus yeast)

≤100CFU/g

20CFU/g

Escherichia Coli

Absence

Absence

Salmonella species

Absence

Absence

mould plus yeast

≤50CFU/g

Absence

Features and applications:

SBE-β-CD 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.


SBE-β-CD has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.


Looking for ideal FDA Approved Sulfobutyl Ether Beta Cyclodextrin Manufacturer & supplier ? We have a wide selection at great prices to help you get creative. All the DMF Approved Sulfobutyl Ether Beta Cyclodextrin are quality guaranteed. We are China Origin Factory of Medical Sulfobutyl Ether Beta Cyclodextrin Sodium. If you have any question, please feel free to contact us.

Product Categories : Sulfobutyl/Methyl Beta Cyclodextrin > Sulfobutyl Beta Cyclodextrin

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