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
