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Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
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Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt

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連絡先担当者 Jack

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製品仕様

タイトルまたは説明

DMF No.: *****7

Name: sulfobutyl ether-beta-cyclodextrin sodium salt  

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

CAS NO.: **********0

Abbreviation: SBEBCD

Molecular formula : C*2H**-nO*5 (C4H8O3S Na)n 

Molecular weight: ***5***8n

Qaulity : injection grade / oral grade

Standard : USP*9 / EP9.0

Package: **0g/bag , 1kg/bag , 2kg/bag, *0kg/drum , *0kg/drum or customized

Use : medical 

Specification : USP*9

ITEMS

SPECIFICATION

RESULTS

Appearance

White to off-white solid, free    from foreign matter

Qualify

           Solution Clarity             

A *0%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.**6.9

6.7

SBE 1 Content

≤0.2%

0.*5%

SBE 2 Content

≤0.8%

0.*5%

Water solution pH

pH of    *0%w/v solution in water is 4.**6.8

5.4

Heavy Metals

≤5ppm

<5ppm

Water

≤*0%

4.0%

β-Cyclodextrin Content

≤0.1%

Absence

Sodium Chloride

≤0.2%

0.*1%

1,*-butane sultone

≤0.5ppm

0.3ppm

*-Hydroxybutane**-Sulfonic Acid

≤0.*9%

0.*1%

Disodium bis-(*-sulfobtyl) ether

≤0.*5%

0.*5%

Assay

*5%***5%

*9.5%

Bacterial endotoxins

≤*5EU/g

≤*0EU/g

Microbiology

Total viable aerobic count (mould plus yeast)

≤**0CFU/g

*0CFU/g

Escherichia Coli

Absence

Absence

Salmonella species

Absence

Absence

mould plus yeast

≤*0CFU/g

Absence

Features and applications:

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.

sulfobutyl ether-beta-cyclodextrin sodium salt  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.

国: China
モデル番号: -
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関連製品 Shandong Binzhou Zhiyuan Biotechnology Co., Ltd

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