HYDROXYPROPYL BETADEX
Hydroxypropyl Betadex is a hydroxyalkylated derivative of Betadex. Hydroxypropyl Betadex can improve the solubility and bioavailability of some insoluble drugs. Therefore, it can effectively improve the bioavailability of drugs, andcontrol release speed and enhance stability.
[CAS NO]: 128446-35-5
DMF 034772
[Molecular formula]: C42H70O35(C3H6O)x
[Specification]: 500g/Bag; 10kg/Bag.
[Category]: Pharmaceutical excipients
[Storage]: Keep airtight and in a dry place.
[Period of validity]: 36 months
| ASSAY | EP | USP |
| Appearance | White or almost white, amorphous or crystalline powder | White or almost white, amorphous or crystalline powder |
| Clarity of solution | See EP10.0 | See USP-NF2021, Issue1 |
| Loss on drying | Maximum 10.0% | NMT 10.0% |
| Betadex | Maximum 1.5% | NMT 1.5% |
| Propylene glycol | Maximum 2.5% | NMT 2.5% |
| Any other single impurity | / | NMT 0.25% |
| Total impurities excluding betadex and propylene glycol | Maximum 1.0% | NMT 1.0% |
| Propylene oxide | / | NMT 0.0001% |
| Molar substitution | 0.40-1.50 | 0.40-1.50 |
| Conductivity | Maximum 200μS.cm-1 | Maximum 200μS.cm-1 |
| Microbial limit | Corporate internal control standards |
| The total aerobic microbial count | ≤10CFU/g |
| The total combined molds and yeasts count | ≤10CFU/g |
| Escherichia coli | Not detectable |
| Bacterial endotoxins | ＜10IU/g |
Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is
alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an
anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium
can bewell combined with the drugmolecules to form non-covalent
therebyenhancingthe stability, water solubility, and safety of the
drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease
rate, covering bad smell, etc.
Betadex Sulfobutyl Ether Sodium
[CAS NO]: 128410-00-0
DMF 034773
[Molecular formula]: C42H70-nO35·(C4H8SO3Na)n
[Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.
[Category]: Pharmaceutical excipients
[Storage]: Seal preservation.
[Period of validity]: 36 months
| Betadex Sulfobutyl Ether Sodium ( EP10.0) | |
| 【CONTENT】 | |
| Sulfobutyl Betadex Sodium | 95.0%-105.0% |
| Average Degree of Substitution | 5.9-6.6 |
| 【CHARACTERS】 | |
| Aooearancce | white or almost white, hygroscopic powder |
| Solubility | freely soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride |
| 【IDENTIFICATION】 | |
| A Infraed Absorption Spectrophotometry |
Complies with SBECD referance |
| B Sodium Reaction |
Positive test for sodium |
| 【TEST】 | |
| PH | 5.0-7.5 |
| Appearance of Solution |
The solution is clear and colourless |
| Reducing Sugars | NMT 0.05% |
| 【IMPURITIES】 | |
| Limit of betadex | NMT 0.1% |
| Limit of 1'2λ6-oxathiane-2,2-dione | NMT 0. 5ppm |
| Limit of 4-hydroxybutane-1-sulfonic acid | NMT 0. 1% |
| Limit of 4,4'-oxydi(butane-1-sulfonic acid) | NMT 0. 05% |
| Limit of soudiun chloride | NMT 0.12% |
| Water | NMT10.0% |
| 【MICROBIAL CONTAMINATION】 | |
| the total aerobic microbial count | NMT 100cfu/g |
| the total combined molds and yeasts count | NMT 100cfu/g |
| Escherichia coli. | absence |
| Salmonella | absence |
Betadex Sulfobutyl Ether Sodium
Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium can bewell combined with the drugmolecules to form non-covalent therebyenhancingthe stability, water solubility, and safety of the drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease rate, covering bad smell, etc.
[CAS NO]: 128410-00-0
DMF 034773
[Molecular formula]: C42H70-nO35·(C4H8SO3Na)n
[Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.
[Category]: Pharmaceutical excipients
[Storage]: Seal preservation.
[Period of validity]: 36 months
| Betadex Sulfobutyl Ether Sodium (USP-NF2021, Issue 1) | |
|
ASSAY |
SPECIFICATION |
|
【IDENTIFICATION】 |
|
|
A |
Complies with SBECD reference |
|
B |
tR of the major peak complies with SBECD reference |
|
C |
meets the requirements of the test for Average Degree of Substitution. |
|
D |
Positive test for sodium |
|
【ASSAY】 |
|
|
The Percentage of Betadex SulfobutylL Ether Sodium |
95.0%-105.0% on the anhydrous basis |
|
【IMPURITIES】 |
|
|
limit of Beta Cyclodextrin |
NMT 0.1% |
|
limit of 1,4-Butane Sultone |
NMT 0.5ppm |
|
limit of Sodium chloride |
NMT 0.2% |
|
limit of 4-Hydroxybutane-1-sulfonic acid |
NMT 0.09% |
|
limit of Bis(4-sulfobutyl) ether disodium |
NMT 0.05% |
|
Bacterial Endotoxins Test |
≤10EU/g |
|
Microbial Enumeration Tests |
|
|
The total aerobic microbial count |
NMT 100cfu/g |
|
The total combined molds and yeasts count |
NMT 50cfu/g |
|
Tests for Specified Microorganisms |
Absence of Escherichia Coli/1g |
|
Clarity of Solution(30%,w/v) |
The solution is clear, and essentially free from particles of foreign matter |
|
Average Degree of Substitution |
6.2-6.9 |
|
Ether Sodium Peaks I-X |
Limit Range(%Peak Area) |
|
I |
0-0.3 |
|
II |
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 |
0-4.0 |
|
pH |
4.0-6.8 |
|
Water Determination |
NMT 10% |
Xi'an DELI Biochemical Industry Co.,Ltd.
Tel: +86-29 87860211
E-mail: xadl@xadl.com
Add: 9 Lifeng road, Daixin Industrial Park Lintong District Xi'an, Shaanxi Province, China