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Betadex Sulfobutyl Ether Sodium

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  • Betadex Sulfobutyl Ether Sodium
  • Betadex Sulfobutyl Ether Sodium
  • Betadex Sulfobutyl Ether Sodium
  • Betadex Sulfobutyl Ether Sodium
  • Betadex Sulfobutyl Ether Sodium

›

Betadex Sulfobutyl Ether Sodium

CAS NO.: 182410-00-0

USA DMF NO.: 29394


Technical Parameter

Other name:Sulfobutyl ether Beta Cyclodextrin Sodium

Appearance：White powder,sweet,insipid and innocuous

Shelf life：36 Months

Grade：Injection

Application：Pharmaceuticals

Molecular Weight：1347

Standard：USP38, In-house Standard

Solubility：≥100(25℃,g/100ml)

Heavy metal：≤0.0025%


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Certificate of Analysis for Betadex Sulfobutyl Ether Sodium


StandardUSP-NF、Enterprise Standard and EP
ItemSpecification
Appearance(USP)White to off-white, amorphous powder(USP)
IRThe infrared absorption spectrum is consistentwith that of the Standard
HPLCThe retention time of the major peak of theSample solution corresponds to that of theStandard solution

Average Degree of Substitution

Meets the requirements ofthe test for AverageDegree of Substitution
SodiumGives the reactions of Sodium
Clarity ofSolutionThe solution is clear and essentially free from particles of foreign matter
Assay (Calculated on the anhydrous basis)95.0~105.0
Heavy Metals(ppm)≤5
Beta Cyclodextrin (Betadex)(%)≤0.1
1,4-Butane Sultone(ppm)≤0.2
Sodium Chloride(%)≤0.2
4-Hydroxybutane-1-sulfonic Acid(%)≤0.09
(4-sulfobutyl) ether Disodium(%)≤0.05
Bacterial Endotoxins(EU/mg)<0.02
The Total Aerobic Microbial Count (cfu/g)≤100
The Total Combined Molds and Yeasts Count (cfug)≤50
Escherichia Coli
Absent
Average Degree of Substitution
6.2~6.9
PH4.0~6.8
Water Determination(%)
≤10


Product Description


Sulfobutyl ether beta cyclodextrin sodium 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.


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.

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