Betadex Sulfobutyl Ether Sodium (SBECD)

Injectable Grade (US-DMF)

CAS #:

182410-00-0

Molecular Formula:

C42H70-nO35 . (C4H8SO3Na)n

Synonym:

Beta cyclodextrin sulfobutyl ether sodium

Molecular Weight:

2242.04 g/mol

Overview

Sulfobutyl ether β-cyclodextrin sodium (also called Betadex sulfobutyl ether sodium) is a chemically modified β-cyclodextrin used as drug delivery system. It is applied to injectable drugs to improve the solubility of difficult soluble drugs, can make the drug injections in the rapid transfer and reach the required dosage, reduce irritation to the parts injected, improve the stability of the drug solution and to improve the safety of medication.

Characters Unit Specification
Appearance White to off white powder
Identification by FT-IR Conforms to reference spectrum
Identification of sodium The flame test for sodium imparts an intense yellow color
Identification by HPLC RT of major peak of the sample solution corresponds to that of the standard solution
Average Degree of substitution 6.2-6.9 for average degree of substitution
Assay by (HPLC %w/w) 95.0-105.0 on the anhydrous basis
Impurities
Impurities by HPLC 1 ,4-Butane sultone NMT 0.5ppm
Impurities by GC NaCI NMT 0.2% 119670/4-Hydroxybutane-1-sulfonic acid NMT 0.09% 119669/Bis(sulfobutyl) ether disodium MNT 0.05%
Impurities by IC
Residual solvents ppm DCM NMT 600ppm 1 ,4-dioxane NMT 380ppm
Heavy metals ppm NMT 5 ppm
Specific Tests
Water content (%w/w) NMT 10.0
pH 4.0-6.8
Clarity of solution Report result
Bacterial endotoxins Report result
Total Aerobic Microbial Count (TAMC) Report result
Total molds and Yeast Count (TYMC) Report result
Escherichia Coli. Report result

Shelf Life/Retest Date: The minimal shelf-life of Betadex Sulfobutyl Ether Sodium (SBECD), CAS 182410-00-0 is 24 months when stored under recommended conditions.

Storage/Shipping Conditions:

  • Preserve in well-closed containers.
  • Store at or below 25°C.
  • Protect from moisture.

Pack Sizes: 100 gm and 1 Kg

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