Product Detail

Name: Betadex sulfobutyl ether sodium

CAS NO. : 182410-00-0

DMF No.: 030167

Sulfobutyl Ether-ß-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.

 

Molecular Formula:C₄₂H_70-nO₃₅ (C₄H₈O₃S Na)n

Molecular Weight :  1135+158n

 Product Specification of Sulfobutyl Ether-ß-cyclodextrin Sodium salt 

Standard	USP40-NF35
ITEMS	SPECIFICATION
Clarity of Solution	A 30%w/v solution in water is clear and essentially free from particles of foreign matter
Identification (IR)	Same absorption bands as USP betadex sulfobutyl ether sodium RS
Identification(Sodium)	Identify test are positive for Sodium
Identification(LC)	the retention time of the major peak of  sample solution corresponds to the  standard solution
Average Degree of Substitution	6.2-6.9
Water solution pH	pH of 30%w/v solution in water is 4.0-6.8
Heavy Metals	=5ppm
Water content	=10.0%
ß-Cyclodextrin Content	=0.1%
Sodium Chloride	=0.2%
1,4-butane sultone	=0.5ppm
4-Hydroxybutane-1-Sulfonic Acid	=0.09%
Disodium bis-(4-sulfobtyl) ether	=0.05%
Assay	95.0%-105.0%
Bacterial endotoxins	=20EU/g
Microbiology
TAMC ( cfu/g)	=100 cfu/g
TYMC ( cfu/g)	=50 cfu/g
Escherichia Coli	Absence

 

 

Primary Competitive Advantages:

• Possess of excellent quality guarantee system,adopt advanced testing equipment and Quality manage method.

•  Experienced Staff & Advanced production technology & Stable quality

• Packaging

• Factory Price

• Prompt Delivery

• Quality Approvals

• Small Orders Accepted

• Payment terms

   

  Packing & Shipping

  Packing Detail       : 500g/bag, 1kg/bag, 2kg/bag, 10kg/drum, 20kg/drum or other quantity just as you requests.

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Generally, Our policy is to dispatch all 'in stock' orders within 1-3 working days.

Occasionally, we are out of stock of an item ordered within 3-10 working days.

 If we are not going to be able to dispatch the item within 3 days we will contact you to advise on the situation. Should you wish to change the order you can do so at that time.

FAQ

• Does your company is a factory or trade company ?

• We are Manufacturer, we have production experience of over 7 years with a high reputation and cognition degree in the cyclodextrin field.

   

l What's the main advantages about your Sulfobutyl Ether-ß-cyclodextrin Sodium salt?

• Factory direct sale,we can provide you high quality product and competitive price.

   

• What’s the quality assurance you provided?

• Established a procedure to check products at all stages of the manufacturing process-raw materials, process materials, validated or tested materials finished goods etc.. Besides, we have also developed a procedure which identifies the inspection and test status of all stages of the manufacturing process.

   

• How do you control quality?

• 100% inspection in assembly lines. All controls, inspection, equipment, fixtures, total production resources and skills are inspected to ensure they consistently achieve the required quality levels. our product is under the supervision of QA and QC,firmly conforms to GMP standard.

   

• Can purchaser come to audit?

• We warmly welcome customers' audit,it's an effective way to build a better business relationship.