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Betadex Sulfobutyl Ether Sodium msds

Betadex Sulfobutyl Ether Sodium msds

Sulfobutyl ether beta cyclodextrin sodium ( SBE-β-CD ) CAS NO.: 182410-00-0 Standard: USP, In-house Standard DMF No.: 29394 Appearance: White powder,sweet,insipid and innocuous Shelf life: 36 Months Grade: Injection Application: Pharmaceuticals Main Application: solubilizer, wetting agent,...

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Product Details

Sulfobutyl ether beta cyclodextrin sodium ( SBE-β-CD )


CAS NO.: 182410-00-0

Standard: USP, In-house Standard    DMF No.: 29394

Appearance: White powder,sweet,insipid and innocuous  

Shelf life: 36 Months  

Grade: Injection  

Application: Pharmaceuticals

Main Application: solubilizer, wetting agent, chelating agent (complexing agent) and polyvalent masking agent.

Molecular Weight: 1347  

Solubility: ≥100(25℃,g/100ml)  

Heavy metal: ≤0.0025%

MOQ: 1kg    Workshop: GMP    Audit: Approved    Sample: free of charge  

 

Sulfobutyl ether beta cyclodextrin sodium ( Betadex sulfobutyl ether sodium, SBE-β-CD ) is a new type of anionic high soluble cyclodextrin derivatives. It could include drug molecules to from covalent compounds so that increase the drug’s stability,solubility,safety.It could reduce the renal toxicity,moderate drug’s hemolysis,control the release rate and cover up the bad smell.

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It 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 could has a special affinity and inclusion for nitrogen drugs.

 

Specification ( USP Standard)

Iterm

Specification


Appearance

White to off-white, amorphous powder


Solubility

 

Freely soluble in water and in propylene glycol


 

Identification

IR

The infrared absorption spectrum is consistent with that of the Standard

HPLC

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution


Average Degree of Substitution

Meets the requirements of the test for Average Degree of Substitution


Sodium

Gives the reactions of the Sodium


Clarity

The solution is clear and essentially free from particles of  foreign matter


Assay ( % )

95.0-105.0


Heavy Metals ( ppm )

≤5


Limit of Beta Cyclodextrin ( Betadex ) ( % )

≤0.1


Limit of 1,4-Butane Sultone ( ppm )

≤0.5


Limit of Sodium Chloride ( % )

≤0.2


Limit of 4-Hydroxybutane-1-sulfonic Acid ( % )

≤0.09


Limit of and Bis( 4-sulfobutyl )Ether Disodium ( % )

≤0.05


Bacterial Endotoxins ( EU/g)

<20


The total aerobic microbial ( CFU/g )

≤100


The total combined molds and yeasts ( CFU/g )

≤50


Escherichia coli

Absent


Average Degree of Substitution

6.2-6.9


 

 

 

 

 

 

 

Peaks Ⅰ-Ⅹ ( peak area )

0.0-0.3

0.0-0.9


0.5-5.0


2.0-10.0


10.0-20.0


15.0-25.0


20.0-30.0


10.0-25.0


2.0-12.0


0.0-4.0


pH

4.0-6.8


Water Determination ( % )

≤10


 


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