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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]: C₄₂H_70-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	t_R 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%

Betadex Sulfobutyl Ether Sodium (USP)