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

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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%


磺丁基倍他环糊精钠检验标准


标准依据Standard
企业标准和USP-NF2024Enterprise Standard and USP-NF2024
项目Item
指标Specification
外观Appearance
白色无定形粉末(CDE登记标准)白色或几乎白色无定形粉末(USP)White to off-white, amorphous powder(USP)
红外光谱IR
样品的红外吸收图谱应与对照品的红外图谱一致
The infrared absorption spectrum is consistentwith that of the Standard
HPLC
样品液主峰的保留时间应与标准液的保留时间一致The retention time of the major peak of theSample solution corresponds to that of theStandard solution

平均取代度

Average Degree of Substitution

应符合平均取代度的规定
Meets the requirements ofthe test for AverageDegree of Substitution
钠 Sodium
呈钠盐反应Gives the reactions of Sodium
溶液的澄清度Clarity ofSolution
应澄清 The solution is clear and essentially free from particles of foreign matter
含量(按照无水物计,%)
Assay (Calculated on the anhydrous basis)
95.0~105.0
重金属Heavy Metals(ppm)
≤5
倍他环糊精Beta Cyclodextrin (Betadex)(%)
≤0.1
1,4-丁烷磺内酯1,4-Butane Sultone(ppm)
≤0.2
氯化钠Sodium Chloride(%)
≤0.2
4-羟基丁烷-1-磺酸
4-Hydroxybutane-1-sulfonic Acid(%)
≤0.09
双(4-磺丁基)醚二钠Bis(4-sulfobutyl) ether Disodium(%)
≤0.05
细菌内毒素Bacterial Endotoxins(EU/mg)
<0.02
需氧菌总数
The Total Aerobic Microbial Count (cfu/g)
≤100
霉菌和酵母菌
The Total Combined Molds and Yeasts Count (cfug)
≤50
大肠埃希菌Escherichia Coli
不得检出Absent
取代度Average Degree of Substitution
6.2~6.9
PH4.0~6.8
水分Water Determination(%)
≤10



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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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