Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Product Name
|
Factory Supply sulfobutyl beta- cyclodextrin/SBECD
|
CAS No.
|
182410-00-0
194615-04-8
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Appearance
|
White Powder
|
Purity
|
98.0% --101.0%
|
Main application
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It is suitable for solubilization and solubilization of injection drugs
|
Route of administration
|
Injection medicine, oral medicine, nasal medicine and eye medicine have special affinity and inclusion property for nitrogen-containing drugs.
|
Quality standard
|
USP43-NF38
|
Sulfobutyl beta- cyclodextrindetection standard
|
||
Inspection items
|
USP43-NF38
|
|
character
|
White to off-white,amorphous powder.
|
|
Identification
|
IR
|
Same absorption bands as USP betadex sulfobutyl ether sodium RS.
|
HPLC
|
The retention time of the major peak of sample solution corresponds to the standard solution.
|
|
Average Degree of Substitution
|
Conform
|
|
Sodium
|
Identify test are positive for Sodium
|
Assay
|
95.0%~105.0%
|
|
Beta Cyclodextrin
|
≤0.1%
|
|
1,4-Butane Sultone
|
≤0.5ppm
|
|
Sodium Chloride
|
≤0.2%
|
|
4-Hydroxybutane-1-sulfonic Acid
|
≤0.09%
|
|
Bis(4-sulfobtyl) Ether Disodium
|
≤0.05%
|
|
Bacterial Endotoxins
|
≤20EU/g
|
|
The total aerobic microbial count
|
≤100cfu/g
|
|
The total combined moulds and yeasts count
|
≤50cfu/g
|
|
Escherichia coli
|
Absence
|
|
Clarity of Solution
|
30%(w/v) solution is clear and essentially free from particles of foreign matter.
|
|
Average Degree of Substitution
|
6.2~6.9
|
|
Peaks I-X
(%peak area) |
I
|
0.0~0.3
|
II
|
0.0~0.9
|
|
III
|
0.5~5.0
|
|
IV
|
2.0~10.0
|
|
V
|
10.0~20.0
|
|
VI
|
15.0~25.0
|
|
VII
|
20.0~30.0
|
|
VIII
|
10.0~25.0
|
|
IX
|
2.0~12.0
|
|
X
|
0.0~4.0
|
PH value
|
4.0~6.8
|
|
Water content
|
≤10.0%
|
Packing
|
1kg/bag ,25kg/bag;25kg/drum; according to your requirements |
Transit | Fedex, TNT,DHL,EMS,and so on. |
Port | Shanghai/Tianjin/Dalian/Beijing/Xi'an |
Lead Time | 3-5 working days upon received the payment |
For mass orders, it will be delivered by air or sea. Depending on your location, please allow 1-5 business days for your order to arrive. For small order, please expect 3-7 days by UPS DHL EMS. For mass order, please allow 5-8 days by Air, 15-30 days by Sea. |