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 SULFOBUTYL 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

20.0-30.0

10.0-25.0

2.0-12.0

0-4.0

pH

4.0-6.8

WATER DETERMINATION

NMT 10%


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 ( EP10.0)
【CONTENT】
SULFOBUTYLBETADEX SODIUM 95.0%-105.0%
AVERAGE DEGREE OF SUBSTITUTION 5.9-6.6
【CHARACTERS】
APPEARANCE 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 SODIUM 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


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


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